Download 3 - CSCC

Atherosclerosis
Risk in Communitiee Study
Protocol
Manual 6a
Ultrasound Assessment: Scanning Procedures
Visit 3
Version 3.0
January 1995
For Copies, Please Contact
ARIC Coordinating Center
Department of Biostatistics (CSCC)
University of North Carolina at Chapel Hill
CBX 8030, Suite 203, NationsBank Plaza
Chapel Hill, NC 27514
FOREWORD
This manual, entitled Ultrasound Assessment: Scannina Procedures is one ofa
series of protocols and manuals of operation for the AtherosclerosisR i s k in
Corninunities (ARIC) Study. The complexity of the ARIC Study requires that
a
sizeable number of procedures be
described, thus this rather extensive
list of
materials has been organized into the
set of manuals listed below. Manual 1
provides the background, organization, and general objectives of the ARIC
Study. Manuals 2 and 3 describe the operation of the Cohort
and Surveillance
Components of thestudy. Detailed Manuals of Operation for specific
procedures, including those of reading centers and central laboratories, make
up Manuals 4 through 11 and 13 through 15. Manual 12 on Quality Assurance
contains a general description of the study's approach t o quality assurance as
well as the details for quality
control for the different study procedures.
ARIC Study Protocols and Manuals of Operation
MANUAL
1
General
2
Cohort Component Procedures
3
Cohort and Community Surveillance
4
Pulmonary Function Assessment
S
Electrocardiography
6
Ultrasound Assessment
a. Ultrasound Scanning Procedures
b. Ultrasound B-mode Image Reading Protocol
c. Distensibility Scanning Protocol
(Retired)
d. Distensibility Reading Protocol
(Retired)
Description and Study Management
-
(Retired)
-
-
7
Blood Collection and
Processing
8
Lipid and Lipoprotein Determinations
9
Hemostasis
Determinations
Determinations
-
10
Clinical
Chemistry
(Retired)
11
Sitting
Blood
12
Quality Assurance and
Quality
Control
13
Magnetic Resonance Imaging
a. Magnetic Resonance Imaging Protocol
b. Magnetic Resonance Imaging Reading Protocol
14
Retinal Photography
15
Echocardiography
Pressure
MANUAL 6A
TABLE OF CONTENTS
1
.
1
.
3.
2
2
4
ULTRASOUND AREA INSTRUMENTATION
3.1
The Biosound Phase 2 Ultrasound Imaging System
3.2
The Video Cassette Recorder
3.3
The M I Tissue-Mimicking Ultrasound Phantom
3.4
The 486-SX Computer
3.5
The Study Flow Program
3.6
IBM-XT Computer
3.7
Dinamap Automated Blood Pressure Apparatus
.
5
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. . . . . . . . . . . . . .. .. .. .. .. .. ..
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..
EQUIPMENT MAINTENANCE
4.1
Biosound Phase 2 Ultrasound Imaging System
4.2
VideoCassetteRecorder
4.3
RMI 414 B Tissue Mimicking Ultrasound Phantom
4.4
486-SX Computer
4.5
IBM-XT
4.6
Dinamap Automated Blood Pressure
.........
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. DAILY
PRELIMINMIES
. .
.
5.1
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . .
5.2
Biosound Phase 2 setup . . . . . . . . . . . . . . . . . . .
5.3
6
.
7
.
Supplies
0
..........................
ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED
6.1
Priority for Boundary Visualization
6.2
The Carotid Arteries
6.3
Cursor Placement by Site and Side
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. ......
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PARTICIPANT PRELIMINARIES
7.1
Participant Orientation to Ultrasound Examination
7.2
Participant Apparel
7.3
Study Preliminaries
7.4
Preliminary Questionnaire
7.5
BloodPressure
7.6
Preparation €or Ultrasound Examination
...........
a
.
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.
10
.
9
10
21
21
21
23
24
24
24
27
36
36
36
36
37
38
46
CAROTIDSCANS
8.1
Calibration
8.2
Right Carotid Scan
8.3
Left Carotid Scan
8.4
QuestionScreens
8.5
Ultrasound Conclusion
56
56
57
61
65
65
SONOGRAPHER TRAINING. CERTIFICATION AND MONITORING
9.1
Training
9.2
Certification
9.3
Monitoring
9.4
The B-Mode Study Scan Evaluation Form
9.5
The Lead Study Sonographer
74
74
75
79
80
80
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9
6
6
6
6
9
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81
.
11
. . . . .. . . . .
LABELING AND MAILING TO THE ULTRASOUND READING CENTER
11.1 Labeling of Video Cassettes and Diskettes
11.2
Content of Mailing
11.3 Frequency of Mailing
11.4 Package Labeling
11.5 Verification of Mailing
Contents
82
82
82
82
83
83
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. . . ... . . . . . . . . . . . . . . . . .
..............
12
.
14
.
POLICIES/PROCEDURES FOR REPORTING B-MODE ULTRASOUND RESULTS
12.1 Routine
Reporting
12.2
Procedures for Non-routine Results
....
84
84
84
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. .
.
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...
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APPENDICES
APPENDIX I: DOPPLER SIGNAL ID OF THE INTERNAL CAROTID ARTERY
APPENDIX 11: SOFTWARE TROUBLESHOOTING
APPENDIX 111: TROUBLESHOOTING
APPENDIX IV: BIOSOUND KEYBOARD
APPENDIX V: LOG SHEET REFERENCE
APPENDIX VI: VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM
APPENDIX VII: WEEKLY SHIPPING LOG
APPENDIX VIII: INFORMATION REFERENCE SHEET
APPENDIX IX: READING LIST
A -
1
A - 1
A - 2
A - 5
A - 6
A - 7
A
10
A
12
A
13
...................A
.
.
.
.15
iii
MANUAL 6A
LIST OF FIGURES
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
Figure
.
.
.
.
.
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1
2
3
4
5
6
7
8
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9
10
11
12
13
14
15
16
17
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.
.
.
.
Figure 18 .
Figure 19 .
Figure 20 .
Figure 21 .
Figure 22 .
Figure 23 .
Figure 24 .
Figure 25 .
Figure 26 .
Figure 27 .
.
29 .
Figure 28
Figure
.....
....
..
......
Ultrasound Assessment Equipment: Sonographers's Box
Ultrasound Assessment Equipment: Biosound Phase 2 VCR
Ultrasound Assessment Equipment: Biosound Phase 2 Printer
Ultrasound Assessment Equipment: DINAMAP Monitor
Ultrasound Assessment Equipment: Computer .PC 486
Ultrasound Assessment Equipment: Tower PC 486
Ultrasound Assessment Equipment: Computer IBM-XT
Ultrasound AssessmentEquipment: Cabling Connections
Reference
Phantom Placement
Cross Section or Transverse View
of 6 mm Phantom Target
Phantom Filament Images
Schematic of CarotidArtery Segments Interrogated
Common Carotid Artery (all four boundaries visualized)
TheBifurcation
Doppler Tracing: Internal Carotid Artery
Doppler Tracing: External carotid Artery
Doppler tracing: Combination of Internal and External
Carotid
Biosound Screen Calibration Procedure
Image As Seen OnBiosound Monitor: Proper Cursor Placement
Blood Pressure Cuff Placement .Left Ankle
Blood Pressure Cuff Placement .Right Ankle
Right Carotid Artery .Transverse Scan Investigation
Procedure
Right Carotid Artery .Transverse Scan Investigation
Procedure
Right Carotid Artery.Transverse Scan Investigation
Procedure
Right Carotid Artery.Transverse Scan Investigation
Procedure
L
Left Carotid Artery
Transverse Scan Investigation
Procedure
Left Carotid Artery Transverse Scan Investigation
Procedure
Left Carotid Artery Transverse Scan Investigation
Procedure
Left Carotid Artery.Transverse Scan Investigation
Procedure
. . . .. .. .. .. ..
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..
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11
12
13
14
15
16
17
18
19
20
20
30
31
32
33
33
34
34
35
54
55
66
67
68
69
70
71
72
73
1
1.
INTRODUCTION
Theultrasoundexaminationofthe
ARIC c o h o r t p a r t i c i p a n t s c o n s i s t s of t h e
f o l l o w i n gc o m p o n e n t s :
(1) u l t r a s o n i ci m a g i n go ft h e
c a r o t i d arteries i n t h e
n e c ka n d ( 2 ) m o n i t o r i n g of a r t e r i a l blood p r e s s u r e t h r o u g h o u t t h e u l t r a s o u n d
protocol d e t a i l sb o t ht y p e so fp r o c e d u r e s .A d d i t i o n a l
e x a m i n a t i o n .T h i s
i n s t r u c t i o n s f o r m o n i t o r i n g a r t e r i a l blood p r e s s u r e are d e t a i l e d i n t h e
i s i n c l u d e dw i t he a c hD i n a m a p
(Model 1846SX)
Dinamap S e r v i c eM a n u a l ,w h i c h
u n i t .I n t e r p r e t a t i o no ft h eu l t r a s o u n de x a m i n a t i o np e r f o r m e d
at the
(URC) i s d e s c r i b e d i n t h e U l t r a s o u n d A s s e s s m e n t P a r t
U l t r a s o u n dR e a d i n gC e n t e r
2: R e a d i n gP r o t o c o l .
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
- Visit
3 VERSION 3.0 01/95
2
2.
SELECTION OF ULTRASOUND SYSTEM
The ultrasound system selected for use
in the ARIC Visit 1 (1987-1989) and
Visit 2 (1990-1992) exams was the
Biosound 2000 11. Selection of the Biosound
2000 I1 was based on the results a of
series of detailed protocols performed
on systems provided by four different manufacturers, and included in-vitro
tests on excisedarteries, measurement of the transmitted pressure pulse with
a miniature hydrophone transducer, routine system performance measurements On
phantom test objects, and in-vivo evaluations which included considerations of
ease of use by thesonographer. The ultrasound system selected forARIC Visit
3 (1993-1995) is theBiosound Phase 2. The Biosound Phase 2 is the updated
model of the Biosound 2000 11. It was chosen because the older model
is no
longer manufactured and maintenance of a high performance level in the 2000 I1
would be increasingly difficult t o achieve during thisVisit. The Phase 2
performs essentially the same as the
Biosound 2000 11. The improvements
include a lighter transducer probe, an extended (deeper) field of
view,
improved gray scale presentationand a closer adherence t o t h eNTSC standards
for video signals.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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Visit 3 VERSION 3.0 01/95
3
3.
ULTRASOUND AREA INSTRUMEWTATION
ultrasound
The ultrasound area instrumentation consists of a Biosound 2Phase
imaging system, an NEC PC 1/2" Video Cassette Recorder, an M I 414B Tisaue
Mimicking Ultrasound Phantom, a 486-SX computer, an IBM-XT computer, a Dinamap
automated blood pressure machine
and a computer software atudy flow program.
The e-[uipment was designed and selected to assist the sonographer in adhering
to thz protocolsteps. Figures are presented at the end of Section 4,
including a "Cabling ConnectionsReference". A brief description of each
piece of equipment follows.
3.1
The Biosound Phase 2 Ultrasound Imaging System
The Biosound Phase2 system is a high resolution ultrasound imaging system
designed for relatively.shallowanatomical structures such as the extracranial
carotid arterial system. Images of the arteries are obtained using a nominal
8 MHz transducer driven by a motor in a sector scan format. The sector scan
format is presented in a rectilinear
format with a nominallateral view of 2
cm and a depth of5 cm.
. I n addition to theB-mode image, Doppler signals from the arteries can be
obtained, processed and displayed in a frequency versus time format. The
Doppler information is used primarily €or arterial identification.
An 1/2* sVHS video cassette recorder (VCR)is connected to the Biosound Phase
2. The VCR records the ultrasound
video information coming from the video
channel onto the video
cassette.
3.2
The Video Cassette Recorder
The video recorderis an NEC 1/2" sVHS PC-VCR. It was chosen to provide
superior image quality cassettes. The sVHS cassettes are sent to the
Ultrasound Reading Centerfor interpretation.
3.3
The RMI Tissue-Mimicking Ultrasound Phantom
A modified RMI414B tissue mimicking ultrasound phantom with water trough
attachment is used periodically for performance checks on the
Biosound Phase
2. The phantom has arterial mimicking targets of various diameters and
depths. These targets can bescanned from both longitudinal and transverse
directions, and the images and video information can be evaluatedto assess
system performance. The images are recorded on 1/2" sVHS video cassettes and
Sent t o t h eUltrasound Reading Center.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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Visit 3 VERSION 3.0 01/95
4
3.4
The 486-SX Computer
The 486-SX computer is used for multiple purposes in the ultrasound area. The
computer interacts with the sonographer
and ultrasound area equipment
to
perform the followingtasks:
a.
b.
C.
d.
e.
To obtain participant data, such as identification number, birth date,
.race, and gender.
To establish files for participantdata with appropriate names and file
extensions.
To keep a record of the study steps performed, including quality
assurance studies, from the study
flow program.
To determine the frequency of quality assurance studies and the
arterial sites where the quality assurance studies are performed.
TO record data on hard disk for temporary storage and
on diskette to
send to the Ultrasound Reading Center.
The sonographer interacts with the computer during the initial questionnaire
and at the completion of the
study. The study flow program interfaces with
the IBM-XTto control the Dinamap
blood pressure monitor and
to control the
VCR operation. Instructionson the computer screen from
the study flow program
determine whento take blood pressures manually. At other times, blood
pressures are taken automatically by the Dinamap under computer control.
The computer controls the PC-VCR video cassette recorder. The primary purpose
of the PC-VCR
is to record theB-scan video images for reading at the
Ultrasound Reading Center; however, it performs additional tasks. It records
audio commentsof the sonographers as the scan progresses the
forultrasound
readers to aid them in the interpretation of recorded B-mode images.
A s the
B-scan imagesare being recorded,the PC-VCR labels the tape with an address
on a frame-by-frame
basis. The frame address is used at the reader station
for frame identification and
to compare frame selection among readers.
A sonographer box transmits signals
to the 486 computer. These signals,
initiated either by push buttons or foot switches, advance the study flow
program throughthe steps of the scanning program.
When the sonographer has acquired
the best images obtainable at a site, the
sonographer footswitch is pressed and detected by the computer.
The frame
address on the video tape is and
readstored, and an audio tone is placed
on
the audio channel. The frame address is later placed fi'le
in afor use at the
reader station. The audio tone identifies
portions of the video cassette that
the sonographer feels are the best obtainable views of a site and aids
and/or reviewers in finding particular sections
on thecassette.
3.5
The Study Flow Program
The B-mode ultrasound examination consists
of bilateral carotid artery studies
and involves a minimum
of 10 steps, performed in a similar sequence for each
participant. A study flow program assists the sonographer during the
examination by formatting and displaying computer screens showing tosteps
be
completed and steps which have been
completed. A manual override box is
available for making any changes in the programmed sequence.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
reader
5
3.6
IBM-XT Computer
The IBM-XT computer is used to initiate the Dinamap for blood pressure
measurements. All measurement results are stored on the IBM-XT until the
ultrasound exam is over. The results arestored on a 5 114" floppy disk.
That floppy is inserted into theAI drive on the 486 computer and transferred
t o a -112"
3
floppy fortransfer to theUltrasound Reading Center.
3.7
Dinamap Automated Blood Pressure Apparatus
A series
of blood pressure measurements is made during the ultrasound
examination. The purposes are to provide baseline supine, seated, and
standing blood pressure measurements and to estimate anankle-arm index.
Blood pressure is measured using the Dinamap Model 1846 SX, an automated,
oscillometric device.
The Dinamap Operation Manual should be read carefully
before performing the blood pressure measurements. The timing of blood
pressure measurements and the sequencing of the Dinamap Model 1846
SX are
determined by the IBM-XT.
The Dinamap Servicemanual is included witheach machine at the time of
purchase. If that manual is lost, another can be orderedfrom the Dinamap
zone office.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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3 VERSION 3.0 01/95
4.
EQUIPMEW MAINTENANCE
E q u i p m e n tm a i n t e n a n c e i s p e r f o r m e dp e r i o d i c a l l y .
Detailed r e c o r d s of
m a i n t e n a n c e are t o be k e p t a t e a c h f i e l d c e n t e r b y t h e c h i e f s o n o g r a p h e r .
4.1
B i o s o u n dP h a s e
2 Ultrasound
Imaging
System
is r e q u i r e d t o haveBiosoundrepresentativesperform
a
Each field center
p r e v e n t i v em a i n t e n a n c ec h e c kf o u r
times a y e a r , a n d t o s e n d copies o f a l l
Biosound r e p o r t s t o t h eU l t r a s o u n dR e a d i n gC e n t e r .
More f r e q u e n t service
v i s i t s may be required i f a n y p r o b l e m s o c c u r b e t w e e n s c h e d u l e d p r e v e n t a t i v e
maintenancevisits.
The a i r f i l t e r o nt h eB i o s o u n d
P h a s e 2 i s r e m o v e da n dc l e a n e dm o n t h l y .T h i s
h e l p s t o encourage a i r f l o w t o keeptheequipment
cool a n d operating more
reliably.
Thetransducerhead
i s t o be e x a m i n e d f o r a i r b u b b l e s d a i l y before s c a n n i n g is
attempted. F o l l o wB i o s o u n dp r o c e d u r e s
t o remove a i r b u b b l e s .
4.2
Video Cassette Recorder
The Video Cassette R e c o r d e r s h o u l d be c l e a n e d e v e r y s i x m o n t h s b y
a Biosound
to the field
technician during one of their preventive maintenance visits
center.
4.3
MI 4 1 4 B Tissue MimickingUltrasoundPhantom
The RXI 414B phantom i s checkedweekly t o be s u r e a l l seals are t i g h t a n d t h a t
care a n d
t h et i s s u em i m i c k i n gg e li n s i d eh a sn o td r i e do u t .P r o p e r
t e s t phantom i s d e s c r i b e d i n t h e i n s t r u c t i o n m a n u a l
maintenanceofthe
accompanyingthephantom.Thephantoms
are stored i n a n a i r t i g h t ,
resealable
p l a s t i c c o n t a i n e r . A f e wd r o p s of water o r a w e t s p o n g es h o u l d be added t o
t h i s c o n t a i n e r b e f o r e s e a l i n g t o minimize desiccation of t h e ' t i s s u e m i m i c k i n g
material. P h a n t o ms p e c i f i c a t i o n s are f o u n di nt h ep h a n t o mi n s t r u c t i o nm a n u a l .
Ultrasound
Equipment
Performance
Check
4.3.1
An o n g o i n g q u a l i t y a s s u r a n c e c h e c k
of B i o s o u n d i n s t r u m e n t s i s p e r f o r m e d twice
a month a t e a c h f i e l d c e n t e r . T h i s i s a c c o m p l i s h e db y a s c a n of i d e n t i c a l RXI
T i s s u eM i m i c k i n gP h a n t o m s .T h e
scans a r e s e n t t o t h e u l t r a s o u n d R e a d i n g
Centerforevaluationandconsist
of o n e s c a n of a 6 mm diameter s i m u l a t e d
a set of f i l a m e n t s w i t h i n t h e
v e s s e l w i t h i n t h e p h a n t o ma n do n es c a no f
phantom.
T h ef o l l o w i n gi n s t r u m e n tp e r f o r m a n c e
protocol i s doneby a c e r t i f i e d
s o n o g r a p h e r a t e a c h f i e l d center o n t h e s e c o n d a n d f o u r t h W e d n e s d a y s a f t e r t h e
B i o s o u n du l t r a s o u n ds y s t e mh a sb e e np e r m i t t e d
t o w a r m u p f o r a t l e a s t 30
m i n u t e s .I na d d i t i o n ,t h e
procedure i s a l w a v sr e p e a t e da f t e rt h ef o l l o w i n g :
a.
b.
A f t e r a m a n u f a c t u r e r ' ss e r v i c e
c a l l i s performed on t h eB i o s o u n d
instrument,
A f t e trh et r a n s d u c e r
is repaired or replaced.
A log i s maintained t o i n s u r e t h e s e
tests are p e r f o r m e d per t h e a b o v e
schedule.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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V i s i t 3 VERSION 3.0 01/95
7
The scan of identical phantoms at each field center provides dataanfor
ongoing quality assurance program to monitor
the performance of each Biosound
instrument. Through this program, uniform standards
are maintained throughout
the project.
The RMI 414B ultrasound phantom is placed upright
on the examination table
of the rectangular case parallel
to the longer side of the
with the LONG side
table. The end of the phantom containing the filaments ranging from
0.5 to
4.0 cm should be positioned closest
to the head of the table. (Figure 9).
The top surface
of the phantom is cleaned with a damp cloth or paper
to towel
remove residue. The water tray on the
top of the phantom is half-filled with
tap water to permit efficient coupling of the ultrasound transducer
to the
tissue equivalent medium. DO NOT USE GEL AS THE COUPLING MEDIUM. Minimal
pressure is exerted on the phantom surfacethe
with
transducer throughout the
scan. Excessive pressure or gel on the phantom surface
can cause severe
damage to the phantom.
two minute segment of B-mode phantom images is recorded during this
described below. Use a separate sVHS video tape
to record
phantom
images. Selected frames are read at the Ultrasound Reading Center
to
quantitatively document the ultrasound system imaging characteristics.
A
:
a
check
Set the VCR display screen
to be sure the channel display is set at L. If the
"L" is not
displayed-, pressthe upand down arrowkeys on the VCR keyboard
labeled "Channel" until it does appear.
Press the letter
"D" on the Phase
2 keyboard and wait€or Main Menu to appear
on the bottomof the right monitor screen of the 2.
Phase
Select
PROBE1, located on
the
Phase
2 keyboard.
Make sure the "LUT LN" setting is on the third line
the right
of
Phase2
monitor. If the "LUTLN'* is not present, press
the blue IMAGE PROCESS key
and
select "LINEAR". "LUT LN" will be displayedthe
in upper right portion of the
keys located at the top Of
screen. (Note:
The Menu keys are the five black
the Phase 2 keyboard.)
Check the image orientation. It must be in standard mode. At
the main menu,
press the Image control option, then press TGC
theoption. Last, press the
Standard option. Once these steps are completed return
to the main menu
by
pressing Escape until the main menu appears.
TO enter
a.
b.
C.
d.
ARIC
phantom
information
on the
tape
menu
screen,
do the following:
Press the fourth menu key to display the Setup menu.
Press the first menu key to display Patient menu. Press the first menu
key again. NAME becomes highlighted. Type in the phantom Serial
number and the transducer serial number, separated by a space. Press
the RETURN key.
Press second menu key for Participant ID information.
Type in the
field center location and sonographer ID number. Press
the RETURN key
to return to the Patient menu.
When all entries have been made, press the ESCAPE
key twice to reach
the MqinMenu.
-
PROTOCOL6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
as
8
The Doppler cursor can be removed
by pressing the green DOP CURSOR key located
on the Phase2 keyboard. This key may be toggledON o r OFF. Place Doppler
cursor inthe middle section of the screen.
To put the crosshair on the image to define the
for landmark identification, do the following:
a.
b.
C.
d.
e.
The
vertical
center
of
the
screen
Press the third menu key to display the Calculate menu.
Press the first menu key to display Distance menu.
Press the first menu key again for "Distance plus". the cursor will ,
appear in the upper portion
of the screen.
Move the cursor to the vertical center position identified bythe
doppler cursor, and make certain it is kept
the in
vertical center when
it is moved during
the performance check. The transducer power is
activated, and the system is placed in the normal B-scan imaging mode.
The transducer focus setting
is placed in the
3.0 cm focus position
(Far focus).
Adjust video gain to 50% and adjust TGC settings for optimal imaging.
sonographer
enters
the
RECORD mode by turning off
the
pause
switch
on the
NEC PC-VCR, and scans the phantom. Throuahout the scan, exert only minimal
pressure on the phantom surface
with the transducer. To obtain the images
in
this procedure the long dFmension of the white transducer plate is
to parallel
the long dimension of th-- phantom. The sonographer obtains a cross-sectional
view of the most superficially ( 2 cm depth) located simulated vessels and then
positions the larger ( 6 mm diameter) of the three vessels the
in vertical
center of the screen as confirmed
by the cursor position. Toggle the Doppler
cursor OFF. The crosshair should
be contained well within the outline
of the
vessel, insuring that it does not obscure the reflections from the
or far
near
walls (Figure 10). When a satisfactory image is seen
on the screen, mark this
point on the tape for Ultrasound
the
Reading Center.
The sonographer moves the transducer toward the the
headtable
of
in order
to
view the set of filaments ranging from
0.5 to 4 . 0 cm. These are also viewed
in cross-section, making certain the transducer focus setting the
is 3.0
in cm
position. Using the crosshairas a guide, the filaments are lined
up so that
they are centered horizontally across the center
the ofscreen (Figure
11).
The cursor is positioned in the middle of the screen, taking
to avoid
care
obscuring any of the filament reflections. The reflections of the deeper
filaments will have gaps in them due to shadowing caused by the filaments
superficial to them (Figure 11). Those gaps are used as
an aid in liningup
the filaments properly. When a satisfactory image is seen, the select
footswitch to mark this image.
This concludes the weekly instrument performance test
on the RMI phantom. The
water is carefully removed from
the phantom, and the phantom is returned
to
its storage location in
the manner described in Section
4.3.
Each phantom tape is labeled according to the following format:
-
-
PHANTOM
F- 93
03 - 12 - 001
F
= the fieldcentercode
93
= the year the tape is started
09
= the month the tape is started
12
= the month the tape is complete (left blank until tape is full)
001
= sequential number of each tape (begins with
001 at each field center)
ARIC PROTOCOL 6a. Ultrasound
Scanning Procedures
- Visit 3 VERSION 3.0 01/95
9
This label should be placed
on the videocassette. The video cassette box
should alsobe labeled accordingly. At the end of each week,
the cassetteis
shipped to the Ultrasound Reading Center with
the current shipment of B-mode
tapes. A second tape is used
to record the next week's scan(s) and
a third
tape for the week after. These three tapes will be rotated until they are
full. Completed tapes willbe stored at the Ultrasound Reading Center, and
another tape will be started at the field center when this occurs.
4.3.2
Additional
Points
While scanning
following:
the
to Remember
phantoms,
the
sonographer
to look
is
for
changes
in
the
shape of simulated vessels (these should appear circular)
the gain settings required
to obtain adequate images, or
the focal settings required to obtain images.
If the sonographer notices changes in any of these conditions, he/she should
do the following:
Contact the Biosound technician authorizedto work with this instrument
(Bob Nitsch 8001428-7378) and
Contact the Ultrasound Coordinator at the Ultrasound Reading Center at
(910)759-2137 and report
the actionto be taken by the Biosound
technician
Note: Other Biosound personnel should not work
on the instrument unless
specifically authorized by Mr. Nitsch.
If
.r
the
phantom
surface
begins
to cave
in
or
pucker:
Call the supplier
to arrange service.
Notify the Ultrasound Reading Center Coordinator immediately.
Following any service call,
the chief sonographer isto send a copy
service reportto the URC Coordinator and/or Phantom reader.
of
the
It is important
to vary the location of the transducer within the prescribed
areas on the phantom when doing the scans,
i.e., position in the center, left
Of center, right of center, in order to extend the life of the phantom.
4.4
486-SX Computer
exception
In general, no maintenance is required on the computer with
the
that, if there is one, the clock battery is replaced annually.
In case of
appropriate
system problems, the field center data coordinator contacts
the
authorized repair facility.
4.5
any
IBM-XT Computer
except
ion
on the computer with the
In general,no maintenance is required
that, if there is one,
the clock battery is replaced annually.
In case of
any
system problems, the field center data coordinator contacts
the
appropriate
authorized repair facility.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
Visit 3 VERSION3.0 01/95
10
4.6
Dinamap Automated Blood Pressure
It is recommended that the Dinamap
Model 1846 SX be calibrated every six
months using calibration proceduresin the Dinamap instructionmanual. Copies
of calibration reportsare to be forwarded to the Ultrasound Reading
Center.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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3 VERSION 3.0 01/95
11
SONOGRAPHER’S BOX
STOP
STUDY
SCREEN
SELECT
0
@ gF
PREV.
SCREEN
FRONT PANEL
TO NEXT SITE
I
TO COMPUTER
AUDIO
OUT
FooTSWITCH
TO SELECT
FOOTSWITCH
REAR PANEL
Figure 1.
Ultrasound Assessment Equipment:
Sonographers’s
ARIC PROTOCOL 6a. Ultrasound Scanning P r o c e d u r e s
- Visit
BOX
3 VERSION 3 . 0 0 1 / 9 5
12
BIOSOUND PHASE 2 - REAR PANEL SHOWING VCR
OUTPUTTO
COMPUTER
1
I
RS-232C/
CASSETTE
RECORDER
UL LABEL
ANT
IN
I
L
OUTPUT
TO
+
TRACKER
#'(RF IN)
l
+lRFOUT@
OUTPUT TO
TRACKER C2
(TRIG IN)
0'
BIOSOUND PHASE 2 REAR PANEL CONNECTIONS
TRIG
VCR
Figure 2.
ARIC
Ultrasound Assessment Equipment:
Biosound Phase 2 VCR
PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
13
REAR OF BIOSOUND PHASE 2 - VIDEO PRINTER
MODE 1
MODE 2
Dl P SWITCHES
v
TO VIDEO
PRINTER
f"
CON NE CTl ON
PHASE2REAR
I
D
E
0
-
R
H
H-PO
AC LINE
E
M
0
T
0
E
I
G
POWER SUPPLY
FUSE SPECIFICATION
MONITOR
Figure 3 .
UltrasoundAssessment
Equipment:
ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g
MONITOR
BiosoundPhase
Procedures
-
2 Printer
V i s i t 3 VERSION 3.0 01/95
14
MAP u
l
l
y
OPLRATION
(rn)
PULSE
OTEU
1
I 8I
9
Figure 4.
2
I
7
Ultrasound Assessment Equipment:
Monitor
DIN-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
V i s i t 3 VERSION 3.0 01/95
15
-
Computer
PC 486
F a c i n g Rear P a n e l
1
Inpu.ts from
S o n o g r a p h e r ' s Box
(Red l i n e upward)
<z>
power
I n p u t s ' f r o m P h a s e I1
(Red l i n e on l e f t )
IInputs.fromDinamap
Data I n t e r f a c e
Figure 5.
0-
Ultrasound Assessment Equipment:
U
I n p u t sf r o m
ComputerKeyboard
Computer
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
- PC 486
Visit 3 VERSION 3.0 01/95
16
TOWER COMPUTER -PC, 486
FACING REAR PANEL
-.--
._.""
_
".
"
"
.
rnou roe Box nco
maw
! I t s ON
Figure 6.
Ultrasound Assessment Equipment:
Tower P C 4 8 6
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
17
Vent
not y e d
\
(0 p ul
\
[I ‘ 1 ’ 1
1
not used
Figure 7.
e
to 0th r computer
I
po’wer cable
rnonit/or cable Dhamap cable
keyboard
Ultrasound Assessment Equipment:
Computer IBM-XT
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
18
CABLING C O N N E a I O N S REFERENCE
VTR LEFT AUDIO OUT
WITH
AN LEFT AUDIO
IN
VTR RIGHX AUDIO
WITH
AN RIGHT AUDIO
IN
OUT
VTR RIGHT AUDIO IN
WITH
AN RIGHT AUDIO
OUT
VTR VIDEO OUT
WITH
A N VIDEO
VIR VIDEO IN
WITH
AN VIDEO OUT
NEC VCR POWER
CONNECTION
WITH
POWER SUPPLY
IN
NEC
VCR
A N VIDEO PRINTER
PRINTER VI0 IN
NUMBER 8A
NUMBER 8B
AC LINE
VIDEO PRINTER
Figure 8.
Ultrasound Assessment Equipment.: Cabling Connections Reference
AFtIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
19
Figure 9 .
Phantom Placement
20
Figure 10.
Cross S e c t i o n or Transverse View of 6 mm Phantom Target
Figure 11.
Phantom Filament Images
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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V i s i t 3 VERSION 3.0 01/95
21
5.
DAILY PRELIMINARIES
5.1
Equipment
The equipment in the ultrasound area is turned
on and warmed up for a minimum
of 30 minutes beforeany studies begin. The equipment is
to be turned on in
the followina order:
1.
Biosound Phase 2
2.
NEC VCR
3.
Dinamap
4.
Arterial Wall Tracker
5.
Strip Chart Recorder
6.
Oscilloscope
7.
IBM-XT Computer
8.
486
5.2
Computer
Biosouad Phase 2 Setup
As the unit powers up, the two monitors on the begin
unit to
will
set up their
menus. The monitor on the right displays the main
menu. The menu displays
instructions €or the operator
to finish the boot-up procedure.
When the "Press any key" message appears
on the screen, press the letter
"D"
on the Phase
2 keyboard and wait for Main Menu
to appear on the right monitor
of the Phase2 , at the bottom of screen. If any key other than"D" is pressed
the unit is put into a. "time out"mode. For study purposes a time out mode is
not appropriate. Therefore, the operator should press"D". This will put the
unit in a continuous mode of
operation.
Check the VCR display screen for
VCR setting. Check the channel display for
setting L. If the "L" is not displayed, press the
up and down arrow keys
on
the VCR keyboard labeled "Channel" until it does appear.
-
Visit 3 VERSION 3.0 01/95
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
22
The VCR s e t t i n g s s h o u l d
P a n e l Setti n s s :
be a s f o l l o w s :
Record L e v e l
L = 5
R = a t l e a s t 5 o r more, a d j u s t t o s o n o g r a p h e rp r e f e r e n c e
e x c e e d Red l e v e l o n
Remote C o n t r o l =
TapeRemain
ON
1
2
- not
to
scale d i s p l a y
same a s Remote
R/C S e t t i n g
= T120
Edit = off
L i n e I N = VIDEO
S-VHS = ON
K e y b o a r dS e t t i n s s :
TV/CATV = A I R
( d i s p l a y e d t o t h e r i g h to fc o u n t e r )
Stereo/ L / R / Normal = L = R
D i s p l a y e du n d e ra u d i o
scale
Select PROBE 1, l o c a t e d o nt h eB i o s o u n dP h a s e
u p f o r 30 m i n u t e s .
.
ThePhase
2 b o o t - u pp r o c e d u r e
2 keyboard..Theprobemust
warm
i s now complete.
In order t o obtainthehighestqualityimages
€or t h i s e q u i p m e n t , t h e B i o s o u n d
2 mustbe
i n t h e LUT LN mode.
Check
manual d i r e c t s t h a t t h e B i o s o u n d P h a s e
f o r t h e "LUT LN" s e t t i n g o n t h e t h i r d l i n e o f t h e r i g h t P h a s e 2 m o n i t o r .I f
t h e b l u e IMAGE PROCESS keyand select
t h e "LUT LN" i s n o t p r e s e n t , p r e s s
"LINEAR". T h i s w i l l be d i s p l a y e d i n t h e u p p e r r i g h t
p o r t i o n o f t h e screen.
P r e s s t h e f i r s t menu k e y ,l o c a t e do n
t h e Phase 2 keyboard, t o make s e l e c t i o n
f o r "LUT LN".
A f t e ra c q u i r i n g
"LUT LN", p r e s st h e ESCAPE key.
(NOTE:
Menu
k e y s are t h e f i v e b l a c k k e y s l o c a t e d
at thetopofthePhase
2 keyboard.)
Check t h e image o r i e n t a t i o n .
I t must be i n s t a n d a r d mode.
A t t h em a i n menu,
press t h e TGC o p t i o n .L a s t ,
press t h e
p r e s s t h e Image c o n t r o l o p t i o n , t h e n
Once t h e s e s t e p s a r e c o m p l e t e d r e t u r n t o t h e main menu b y
S t a n d a r do p t i o n .
p r e s s i n g Escape u n t i l t h e m a i n menu a p p e a r s .
ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n gP r o c e d u r e s
- Visit
3 VERSION 3.0 01/95
23
To
a.
b.
C.
de
enter
participant
information
on
the
menu screen, do thefollowing:
tape
Press the 4th menu key to display the Setup menu.
Press the first menu key to display Patient menu. Press the first menu
key again. Name becomes highlighted. Type in participant's last name,
followed by first and middle initials. Press the ESCAPEkey or the
RETURN key.
Press the second menu key for Participant ID information. Type in the
field center identification code, followed by the participant's ID
number. Example: F123456. Press the ESCAPE key or the RETURN key t o
Seturn t o the Patient menu.
When finished, press the ESCAPE key twice t o reach the main Menu.
The Doppler cursor can be removed
by pressing the green DOP
on the Phase2 keyboard. This key may be toggled ON or OFF.
CURSOR
key located
The Phase 2 is now set up for scanning.
5.3
Supplies
The supplies to be used for each day are checked.
following:
a.
b.
C.
d.
e.
f.
This includes the
-
Video cassettes
sVHS cassettes for the NEC PC-VCR
3 112" diskette for each for each video cassette
Participant ID Labels
Identification labels are applied to the video
cassettes and the diskettesused to store participant information.
Aquasonic gel
Paper
wipes
5 114" diskette for each video cassette to be used with IBM-XT
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
24
6.
ARTERIAL SITES AND ANATOMIC STRUCTURES TO BE EXAMINED
Ultrasonic imaging methods are used to obtain a non-invasive quantitative
measure of early atherosclerotic disease. The carotid arteries which the
are
principal suppliersof blood to the brain are a common location for early
disease, primarily within or in close proximity
to the bifurcation. These
arteries, generally located within
a few centimetersof the skin surface, are
well suitedto examination with high resolution ultrasonic imaging methods.
The ultrasound examination concentrates around the segment
the inrightand
left carotid artery known as the carotid bifurcation (See 12).
Figure
Ultrasound examination is attempted 10
at defined siteson the nearand far
walls within thisarea. FoAlowing a preliminary transverse scan,the sitesto
be examined are longitudinally visualized in the middle third
the B-mode
of
image screen with the wall boundaries oriented vertically as nearly as
possible on the screen.
6.1
Priority for Boundary Visualization
In most instances, it is not possible to simultaneously obtain high quality
longitudinal images of both the near and far wall boundaries
of the arterial
segment being examined in the same image frame. This
condition.results
primarily from the highly specular nature of the ultrasonic reflections from
the blood-intima boundaries and the general deviation
the ofarterial geometry
from a cylindrical shape. Consequently, priorities must be placed
on which
arterial wall boundaries should be visualized with the others being visualized
if possible but with potentially lesser quality.
The two boundaries
to be visualized first are the media-adventitia boundary
on
the far wall and the adventitia-media boundary
on the near
wall. This permits
the outer boundaries
of the media to be identified an
andestimateof the
arterial diameter to be measured. The third boundary,the far (deeper) wall
blood-intima, then is visualized while maintaining good images
the of
first
two boundaries. This permitsa measurement of the far wall intimal-medial
thickness. Fourth, if. possible without losing this third boundary,
the
intima-blood boundarv on the near (shallower) wall is visualized. An image of
the common carotid artery in which all four boundaries are visualized is shown
in Figure 13. This sequence of priorities is used when imaging any segment of
the carotid arteries with the exception of special views at the bifurcation
6.2.
and the internal carotid. These are discussed in Section
6.2
The Carotid Arteries
6.2.1
Anatomical References
The arterial segments defined for ultrasonic examination are referenced
to
certain anatomical landmarks which are normally identifiable within the
carotid system. One is the tip
of the flow divider which defines the position
along the vessel where the internal carotid artery and external carotid artery
begin. A second, but less clearly delineated, is the location where
the
common carotid artery begins
to widen into the carotid bifurcation. These
landmarks are illustrated in Figure
12. In order to image defined segments
referenced to these landmarks, longitudinal images are required. During each
image sequence the cursor on the Biosound image screen is placed
the
at
vertical level of the appropriate landmark for use
the reading
in
of the Bmode images at the Ultrasound Reading Center.
ARIC
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PROTOCOL6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
25
6.2.2
O p t i m aIln t e r r o g a t i oA
n ngle
permits c l e a r i d e n t i f i c a t i o n
The optimal u l t r a s o n i c i n t e r r o g a t i o n a n g l e w h i c h
oftheanatomicalreferencesonthe
B-mode i m a g e s d e p e n d s u p o n s p e c i f i c
a n a t o m i c a lf e a t u r e so f
t h e p a r t i c i p a n t .T h i sd e p e n d e n c eo fi n t e r r o g a t i o n
care be g i v e n d u r i n g
angleontheindividualparticipantrequiresthatgreat
t h e p r e l i m i n a r ye x a m i n a t i o n
t o i d e n t i f yt h i sa n g l e .
I t d e p e n d su p o nb o t ht h e
ultrasoundtransducerpositionand
t h e orientation of the head
of t h e
participant
.
I ft h ep r o x i m a ls e g m e n t so ft h ei n t e r n a la n de x t e r n a l
carotid arteries l i e i n
a common p l a n e , it s h o u l d be possible t o i n t e r r o g a t e t h e b i f u r c a t i o n f r o m a n
a “Y” a p p e a r a n c e . T h i s i s
a n g l ew h i c hp r o v i d e sa ni m a g ec h a r a c t e r i z e db y
i l l u s t r a t e di nF i g u r e
14. From t h i s a n g l e , t h e l o c a t i o n o f t h e
two a n a t o m i c a l
references,thetipoftheflowdividerandtheinitial
common c a r o t i d
w i d e n i n g i n t o t h eb i f u r c a t i o n ,c a n
be s e e n .I n
some i n d i v i d u a l s , it is o f t e n
a pronounced
d i f f i c u l t to sharply define t h e origin of the bifurcation if
w i d e n i n g does n o t o c c u r , b u t
it i s most l i k e l y t o be v i s i b l e f r o m t h i s a n g l e .
I f t h e p r o x i m a ls e g m e n t s of t h e i n t e r n a l a n d e x t e r n a l
c a r o t i d a r t e r i e s do n o t
l i e i n a common p l a n e , it may be i m p o s s i b l e f o r t h e s o n o g r a p h e r t o o b t a i n t h e
c h a r a c t e r i s t i c ”Y” a p p e a r a n c e a t t h e b i f u r c a t i o n .
E i t h e r o n e o r t h e o t h e r of
t h eb r a n c h e sc a n
be imaged a t a g i v e n i n t e r r o g a t i o n a n g l e b u t n o t b o t h . I n
many cases, r e p o s i t i o n i n g o f t h e h e a d o f t h e p a r t i c i p a n t
(see S e c t i o n s 8.1.
and 8.2) may p e r m i t t h e t w o arteries t o more c l o s e l y a p p r o a c h a common p l a n e .
O f t e n c a r e f u l a t t e n t i o n t o t h i s p o s i t i o n a n d small p a r t i c i p a n t h e a d a n g l e
c h a n g e s w i l l p e r m i t t h e “Y” t o be v i s u a l i z e d . A p r e l i m i n a r y t r a n s v e r s e s c a n
as described i n S e c t i o n 8.1.3 p e r m i t s the o p t i m a l i n t e r r o g a t i o n a n g l e
t o be
closelyapproximatedeveninthe
more d i f f i c u l t a n a t o m i c a l c o n f i g u r a t i o n s .
6.2.3
The Common Carotid A r t e r y
I m a g e so ft h e
common c a r o t i d a r t e r y a r e o b t a i n e d a t t h e o p t i m a l i n t e r r o g a t i o n
angle:. They are r e f e r e n c e d t o t h e o r i g i n o f t h e b i f u r c a t i o n w h e r e t h e
common
c a r o t i d b e g i n s to widen. T h e s e g m e n tl o c a t e d 10 mm p r o x i m a l t o t h i sl a n d m a r k
i s t h e f o c u s o f a t t e n t i o n . B o t h t h e n e a rw a l la n df a r
wall i n t e r f a c e s are
attempted i n t h i s view.
6.2.4
The C a r o t i d B i f u r c a t i o n
t h e c a r o t i d b i f u r c a t i o n e x t e n d i n g 10 mm p r o x i m a l t o t h e t i p Of
Thesegmentof
i s imaged a t t h e o p t i m a l a n g l e . I n
some p a r t i c i p a n t s t h i s
t h ef l o wd i v i d e r
place t h e c u r s o r a t
may e x t e n d i n t o t h e
common c a r o t i d . Thesonographermust
thelevelofthetipofthe
flow divider.
Images a r e t h e n a c q u i r e d a t t h i s
i n t e r r o g a t i o n a n g l e t a k i n g great c a r e t o use the priority sequence of boundary
visualizationdescribedinSection
6.1.
6.2.5
The I n t e r n a cl a r o t i dA r t e r y
w a l l e x t e n d i n g 10 mm d i s t a l
Thesegmentoftheinternalcarotidarteryfar
from t h e t i p o f t h e flow d i v i d e r i s now imaged a t t h e o p t i m a l a n g l e .
Images
are a c q u i r e d o f t h i s s e g m e n t o n c e a g a i n m a r k i n g t h e
t i p of the flow divider
as
t h e a n a t o m i c a ll a n d m a r k .
I t is i m p o r t a n t t o c a r e f u l l yd i s t i n g u i s hb e t w e e n
the
i n t e r n a la n de x t e r n a lc a r o t i d
a r t e r i e s u s i n g t w o c r i t e r i a : 1. n o r m a l l y t h e
i n t e r n a lh a s a s i g n i f i c a n t l yl a r g e r diameter t h a nt h ee x t e r n a l ;
2. t h e blood
flow v e l o c i t y p a t t e r n i n t h e
t w o vessels as d e t e r m i n e d w i t h D o p p l e r u l t r a s o u n d
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n g
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is d i s t i n c t l yd i f f e r e n t .
Used t o g e t h e r ,t h e s e
t w o c o n s i d e r a t i o n sp e r m i tt h e
i n t e r n a l c a r o t i d a r t e r y t o be i d e n t i f i e d w i t h a h i g h d e g r e e of c o n f i d e n c e .
it i s n e c e s s a r y t o d i s t i n g u i s h
D u r i n gt h ep r e l i m i n a r ys c a n n i n gp r o c e d u r e
c l e a r l yb e t w e e ni n t e r n a la n de x t e r n a l
c a r o t i d arteries. A l t h o u g ht r i b u t a r i e s
,originating from the external carotid artery
may o c c a s i o n a l l y be v i e w e d w i t h
most
B-mode u l t r a s o u n d t o h e l p i n t h i s d i f f e r e n t i a t i o n , D o p p l e r u l t r a s o u n d i n
cases i s more e f f i c i e n t a n d s p e c i f i c
f o r t h i ss e p a r a t i o n .T h em e t h o da n d
criteria f o r t h i s i d e n t i f i c a t i o n a r e
a s follows:
of t h e c a r o t i d b i f u r c a t i o n w h e r e t h e
common c a r o t i d
a r t e r y d i v i d e s .I n
some i n s t a n c e s t h e best a n a t o m i c a la n g l e w i l l show t h e
f l o w d i v i d e r a s well a s t h e p r o x i m a l i n t e r n a l a n d e x t e r n a l
carotid arteries.
In the remaining cases t h e flowdividerandonlyonevesselcan
be s e e n f r o m a
s i n g l ea n g l e .I nt h o s ei n s t a n c e st h eo t h e ra r t e r yc a n
be v i s u a l i z e d b y g e n t l y
r o c k i n g t h e u l t r a s o u n d probe b a c k a n d f o r t h
i n a n g l e or p o s i t i o n or b o t h .
Doppler i s u s e d t o d i f f e r e n t i a t e i n t e r n a l a n d e x t e r n a l c a r o t i d
arteries i n
t h e s ei n s t a n c e s .
To o b t a i n a Doppler s a m p l eo fe a c ha r t e r y ,t h eD o p p l e r
samplevolume
i s p l a c e di n t ot h eb r a n c hf a r t h e s tf r o ms k i ns u r f a c e .T h e
aonographer observes the tracing on the
TV m o n i t o r a n d l i s t e n s
t o theDoppler
signal.
If t h e u l t r a s o u n dp r o b e
is i nt h ei n t e r n a l
c a r o t i d a r t e r y ,t h ef l o w
p a t t e r n w i l l b e t h a t of a l o w - r e s i s t a n c e bed. T h i s s i g n a l h a s a r a p i d
u p s t r o k ea n d a q u a s i - s t e a d y f l o w t h r o u g hs y s t o l ea n dd i a s t o l e .
The flow
c o n t i n u e s t h r o u g h o u t t h e cardiac c y c l e a n d b e g i n s
t o increaseagain a t t h e
nextsystole.
A B-mode image i s o b t a i n e d
The f l o w p a t t e r n i s g r a p h i c a l l yd i s p l a y e dn e a r
t h e z e r ob a s e l i n e .F l o w
d i r e c t e d toward t h e head and awayfrom
t h e heart throughout t h e c y c l e is
represented a s a t r a c i n ga b o v et h e
b a s e l i n e i n F i g u r e 15. I f t h e D o p p l e r
s i g n a l does n o t c o r r e s p o n d t o t h e e x p e c t e d p a t t e r n , t h e c u r s o r
is p l a c e d
w i t h i n t h e o t h e r b r a n c h of t h e common c a r o t i d a r t e r y .
The e x t e r n a l c a r o t i d
a r t e r y is usually nearer the skin surface
when v i e w e d f r o m a n a n t e r i o r a n g l e
and is a h i g h - r e s i s t a n c ev e s s e l .T h ec h a r a c t e r i s t i c so ft h eD o p p l e rs i g n a li n
t h i s v e s s e l are a forward f l o w w i t h a s h a r p u p s t r o k e a n d
sometimes a r e v e r s a l
of t h ef l o w a t d i a s t o l e ( m u l t i p h a s i c ) . The h a l l m a r k of a h i g h - r e s i s t a n c e
a r t e r y i s c e s s a t i o n o f flow b e f o r e t h e o n s e t o f t h e n e x t s y s t o l e
as defined i n
F i g u r e 16.
Abnormal f l o w i s d e m o n s t r a t e d b y t u r b u l e n c e w i t h i n t h e l u m e n a n d d i s r u p t i o n
of
normalflow.
T h i s i s i d e n t i f i e di nt h eD o p p l e rs i g n a lb yb r o a d e n i n gt h e
Doppler s p e c t r u m .S e v e r en a r r o w i n g
of t h e a r t e r y lumen i s i d e n t i f i e d b y a n
i n c r e a s ei nt h ee x p e c t e dp e a ks y s t o l i cf r e q u e n c y .I fo c c l u s i o n
is p r e s e n t
and i n t e r n a l
t h e r e w i l l be no D o p p l e r s i g n a l , i n w h i c h c a s e t h e e x t e r n a l
c a r o t i d a r t e r i e s c a n be d e f i n e d b y t h e e x t e r n a l b e i n g
more a n t e r i o r t o t h e
i n t e r n a la n a t o m i c a l l y .
I f f l o w i s s a m p l e df r o mt h e
common c a r o t i d a r t e r y ,
small r e v e r s a l of f l o w a n d a
t h e r e w i l l be a r a p i d s y s t o l i c u p - s t r o k e w i t h
q u a s i - s t e a d yf l o wt h r o u g h o u td i a s t o l e .T h i s
i s a c o m b i n a t i o no fi n t e r n a la n d
more
e x t e r n a lc a r o t i df l o wp a t t e r n s ,a s
shown i n F i g u r e 17. B e c a u s eo ft h e
v a r i e dp o s i t i o n i n ga n dg e o m e t r y
of t h e i n t e r n a l c a r o t i d , t h e s e q u e n c e o f
p r i o r i t i e s t o be u s e d when imaging t h i s segment i s m o d i f i e d f r o m t h a t u s e d i n
The t w o f a r w a l lb o u n d a r i e ss h o u l dr e c e i v e
t h e common a n d b i f u r c a t i o n .
h i g h e s t p r i o r i t y , t h e n e a r wall a d v e n t i t i a - m e d i a i n t e r f a c e n e x t p r i o r i t y a n d
f i n a l l y t h e n e a rw a l li n t i m a - b l o o db o u n d a r y .
6.2.6
I n d e p e n d e n t V i e w s of t h e Far a n d Near B i f u r c a t i o n Walls
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6.2.6.1
Far w a l l
Afterimagingthefar
wall of t h e i n t e r n a l , t h e
carotid b i f u r c a t i o n a t t h e
optimal a n g l e i s i m a g e da g a i n .
T h e u l t r a s o u n dt r a n s d u c e r is t i l t e d a l o n g t h e
a r t e r i a l a x i s i n s u c h a manner t h a t t h e f a r wall o f t h e b i f u r c a t i o n becomes
v e r t i c a l i n t h e c e n t e r of t h e d i s p l a ys c r e e n .
The q u a l i t y of t h e n e a r w a l l
e c h o e a w i l l d e t e r i o r a t e . A t t h i s time, small c h a n g e si nt r a n s d u c e ra n g l e
are
made eo i m a g e t h e f a r w a l l b l o o d - i n t i m a a n d m e d i a - a d v e n t i t i a i n t e r f a c e s .
A f t e r t h e f a r wall image i s o b t a i n e d , t h e t r a n s d u c e r
i s rotated back t o o b t a i n
t h e c a r o t i d b i f u r c a t i o n optimal a n g l e i m a g e a g a i n .
6.2.6.2
Near w a l l
t h e a x i s o f t h e a r t e r y so t h a t t h e n e a r wall
o f t h e b i f u r c a t i o n i s now o r i e n t e d v e r t i c a l l y i n t h e c e n t e r o f t h e d i s p l a y
w i l l deteriorate. Small changes
s c r e e n .T h eq u a l i t yo ft h ef a rw a l le c h o e s
i n t r a n s d u c e r a n g l e a r e made t o image t h e n e a r w a l l a d v e n t i t i a - m e d i a a n d
i n t i m a - b l o o di n t e r f a c e s .
The t r a n s d u c e r i s r o t a t e d a l o n g
6.3
6.3.1
Cursor P l a c e m e n t by S i t e and S i d e
U l t r a s o u nMd o n i t o r
be marked i n b l a c k on t h e i m a g e s c r e e n o f t h e
Horizontal parallel lines should
u l t r a s o u n d B-mode imagemonitor.
T h e s e l i n e s s e r v e t o delimit t h e optimal
i m a g i n gr e g i o nw h i c h
i s t h i sm i d d l ep o r t i o n
of t h ei m a g e area. T h e s e l i n e s
are referred t o a s t h e u p p e ra n dl o w e ri m a g i n gl i n e s .T h e
two h o r i z o n t a l
18 a r e located where t h e black l i n e s s h o u l d be markedon
l i n e s shownonFigure
are t o b e p o s i t i o n e d 3 / 4 i n c h i n s i d e t h e
top
t h ei m a g es c r e e n .T h e s el i n e s
a n db o t t o mp o r t i o n
of t h e a c t i v e B-mode imaging area. The c r o s s h a i r (+) i s
placed a t t h e l e v e l o f o n e
of these l i n e s t o mark t h e l o c a t i o n o f t h e
s i t e beingimaged.Theplacementof
the
a n a t o m i c a ll a n d m a r kf o rt h es p e c i f i c
c r o s s h a i r i s i l l u s t r a t e d f o r a l l s i t e s i n F i g u r e 19.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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6.3.2
Common CarotidCrosshair
Placement
i s o r i e n t e d so t h a t t h e a r t e r i a l walls appear
The common c a r o t i d a r t e r y i m a g e
v e r t i c a l l y o n t h e m o n i t o rs c r e e n .T h eu l t r a s o u n dt r a n s d u c e r
i s moved so t h a t
theupperimaginglinemarkedontheBiosoundscreenpassesthroughtheorigin
a r t e r i a l walls. T h ec r o s s h a i r is
o ft h eb i f u r c a t i o no nb o t hn e a ra n df a r
p l a c e do nt h eu p p e ri m a g i n gl i n e ,a p p r o x i m a t e l yi nt h e
center of t h e lumen.
lower i m a g i n g l i n e s
Theoptimum u l t r a s o u n d i m a g e a p p e a r s b e t w e e n t h e u p p e r a n d
F o rt h el e f t
common c a r o t i d a r t e r y , t h e
( d e s c r i b e d i n s e c t i o n 6.3.1).
u l t r a s o u n d t r a n s d u c e r i s moved so t h a t t h e lower i m a g i n g l i n e passes t h r o u g h
a r t e r i a l walls. The
t h eo r i g i no ft h eb i f u r c a t i o no nb o t hn e a ra n df a r
lower i m a g i n g l i n e , a p p r o x i m a t e l y i n t h e c e n t e r
of
crosshair is placedonthe
t h e l u m e n .T h eo p t i m u mu l t r a s o u n di m a g ea p p e a r sb e t w e e nt h e
lower a n du p p e r
i m a g i n gl i n e s .
6-3.3
B i f u r c a t i o n Area C r o s s h a i Pr l a c e m e n t
The landmark f o r a l l i m a g e s i n t h e b i f u r c a t i o n a r e a i s t h e t i p o f t h e f l o w
d i v i d e r .I n
some v i e w s , t h e t i p o f t h e
flow d i v i d e r may d i s a p p e a r , b u t t h e
crosshairshouldindicate
i t s l o c a t i o no nt h em o n i t o rs c r e e n .
Fortheright
side, t h e t i p of t h e f l o w d i v i d e r
i s placed o n t h e u p p e ri m a g i n g
l i n e . The c r o s s h a i r i s placed o n t h e u p p e r i m a g i n g l i n e
a t t h e t i p of t h e
f l o wd i v i d e r .T h ec r o s s h a i r
i s placed w i t h i nt h el u m e n ,
t o a s s u r e t h a t it
w i l l b e well c l e a r of a l l measurement areas. T h eo p t i m u mu l t r a s o u n d
image
a p p e a r sb e t w e e nt h eu p p e ra n d
lower imaging l i n e s .
I n t h e t w o v i e w s of t h e b i f u r c a t i o n when o n l y t h e r i g h t f a r w a l l o r n e a r w a l l
i s imaged, t h e t i p of t h e f l o w d i v i d e r i s p l a c e d o n t h e u p p e r i m a g i n g l i n e .
T h e c r o s s h a i r i s a l s op l a c e do nt h eu p p e ri m a g i n gl i n e .T h eu l t r a s o u n d
wall image i s o p t i m i z e d .T h e
t r a n s d u c e r i s m a n i p u l a t e du n t i l t h e f a r o r n e a r
c r o s s h a i r i s t h e n moved t o a p o s i t i o n a l o n g t h e u p p e r i m a g i n g l i n e n e a r
the
wall i n t e r f a c e sb e i n gi m a g e d .T h ec r o s s h a i rs h o u l dn o ti n t e r f e r ew i t ht h e
wallinterfacesbeing
'imaged, b u t r e m a i n i n t h e
lumen area.
F o r t h e l e f t side, t h e t i p o f t h e f l o w d i v i d e r
is p l a c e d o n t h e
lower i m a g i n g
crosshair i s p l a c e d a t t h e t i p o f t h e f l o w d i v i d e r o n t h e
lower
l i n e .T h e
i m a g i n gl i n e .T h eo p t i m u mu l t r a s o u n di m a g ea p p e a r sb e t w e e nt h e
lower a n d t h e
u p p e ri m a g i n gl i n e s .
I n t h e t w o viewsofthebifurcation,
when o n l y t h e l e f t f a r wall o r near wall
is imaged, t h e t i p o f t h e f l o w d i v i d e r is p l a c e d o n t h e
lower i m a g i n g l i n e .
The u l t r a s o u n d t r a n s d u c e r i s m a n i p u l a t e d u n t i l t h e f a r
o r n e a r wall image i s
o p t i m i z e d .T h ec r o s s h a i r
i s t h e n moved t o a p o s i t i o n along t h e lower i m a g i n g
l i n en e a rt h ew a l li n t e r f a c e sb e i n gi m a g e d .
The crosshair s h o u l dn o t
the
i n t e r f e r e w i t h t h e wall i n t e r f a c e sb e i n gi m a g e d ,b u ts h o u l dr e m a i ni n
lumen area.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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6.3.4
Internal Carotid Crosshair Placement
The landmark for the internal carotid
artery is the tipof the flow divider.
Primarily, the far wall of the
internal carotid is imaged.
For the right side, the tip of the flow divider
is placed on the lower imaging
line..': The crosshair is placed on thelower imaging line, approximately in the
center of the lumen. The optimum ultrasound image appears between the lower
and upper imaging lines.
For the left side, the tipof the flow divider is placed on the upper imaging
line. The crosshair is placed on the upperimaging line, approximately in the
center of the lumen. The optimum ultrasound image appears between the upper
and lower imaging lines.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
30
Landmarks
InternalIExternal
Segment
Tip o fF l o wD i v i d e r
Bifurcation
Segment
/-
-O r i g i n
Common Car0 t id
Segment
of B i f u r c a t i o n
I
Figure 12.
Schematic of Carotid Artery Segments Interrogated
ARIC PROTOCOL 6a. U l t r a s o u n d S c a n n i n g P r o c e d u r e s
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Right Common Carotid Artery
-3
I
2
1. Periadeventitial - adventitialnearwall interface
2. Adventitial - medialnearwall
interface
3. Intimal - lumen near wall interface
4. Lumen - intimal far wall interface
5. Medial - adventitial far wall interface
6. Adventitial -.Deriadventitial farwall interface
Figure 13
Common Carotid Artery (all four boundaries visualized)
ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g
Procedures
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Right Carotid Bifurcation
1
6
\
1. Periadeventitial - adventitial near wall interface
2. Adventitial - medialnearwall interface
3. Intimal - lumennearwallinterface
4. Lumen - intimal far wall interface
5. Medial - adventitial far wall interface
6. Adventitial - periadventitial far wall interface
Figure 1 4 .
The B i f u r c a t i o n
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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Internal Carotid Artery
ARIC. PROTOC-L 6a. U l t r a s o u n d . Scanning P r o c e d u r e s
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34
Ti me
Figure 1 7 . D o p p l e rt r a c i n g :
Flow Patterns
Combination of I n t e r n a l and ExternalCarotid
v
’
.
Figure 1 8 .
(Upper)
- (Lower)
BiosoundScreenCalibrationProcedure
ARIC PROTOCOL 6a. UltrasoundScanningProcedures
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Visit 3 VERSION 3.0 01/95
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L e f t Side
Right Side
Common
Optimal Angle
Bifurcation
Internal
Bifurcation
Far Wall
Bifurcation
Near
Mal1
Figure 19.
Image A s Seen On BiosoundMonitor:
ARIC PROTOCOL 6a. UltrasoundScanningProcedures
Proper Cursor Placement
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7.
PARTICIPANT
PRELIMINARIES
t o r e f r a i nf r o ms m o k i n g ,' v i g o r o u s
The p a r t i c i p a n t w i l l h a v eb e e na s k e d
e x e r c i s e ,a n dd r i n k i n gc o f f e e ,
t e a and s o f t d r i n k s c o n t a i n i n g c a f f e i n e d u r i n g
thenightprecedingandthedayoftheultrasoundexamination,sincethese
may
alter h e a r t rate and/orbloodpressure.
7.1
P a r t i c i p a nO
t rientation
t o Ultrasound
Examination
The p a r t i c i p a n t i s p o s i t i o n e d o n t h e e x m i n a t i o n t a l b e i n a s u p i n e p o s i t i o n .
terms t h e e x a m i n a t i o n t o be done. A
T h es o n o g r a p h e rd e s c r i b e si ng e n e r a l
s u g g e s t e ds t a t e m e n tf o l l o w s :
" U l t r a s o u n d i s a new p a i n l e s s a n d l o w - r i s k m e t h o d
t o e x a m i n e arteries u s i n g
a r e a b l e t o 'see' a r t e r i e s u n d e r
s o u n dw a v e sw h i c hy o uc a n n o th e a rb u tw h i c h
y o u rs k i n .B e f o r et h eu l t r a s o u n d
exam b e g i n s , a t h i n g e l w i l l b e applied t o
t h es k i n ,a n d
a n i n s t r u m e n t w i l l b e placed on it. T h i sp r o c e d u r e w i l l be u s e d
t o look a t t h e arteries o n b o t h s i d e s o f y o u r n e c k . D u r i n g t h e e x a m i n a t i o n ,
you w i l l h e a r t h e n o i s e a n d f e e l t h e v i b r a t i o n s
of a small motor t h a t i s
located w i t h i n t h e i n s t r u m e n t . O c c a s i o n a l l y
you w i l l a l s o h e a r t h e a m p l i f i e d
arteries. Theequipment
w i l l a l s o record
s o u n do f blood f l o w i n gt h r o u g hy o u r
my v o i c e a s I name t h e p a r t s of t h e a r t e r i e s I s c a n . T h e complete u l t r a s o u n d
or
e x a m i n a t i o ns h o u l d be c o m p l e t e dw i t h i nf o r t y - f i v em i n u t e s .S i n c et a l k i n g
s w a l l o w i n gc a nc a u s e
t h e a r t e r i e s t o move o u t o f f o c u s a n d c a u s e t h i s
p r o c e d u r e t o t a k el o n g e r ,y o u rc o o p e r a t i o nw o u l db e
appreciated."
Duringthisdiscussion,thesonographershould
remember t h a t t h e e x a m i n a t i o n
t o be d o n e 2 not d i a g n o s t i c i n n a t u r e , a n d
t h a t a l l q u e s t i o n s asked by t h e
p a r t i c i p a n t t h a t r e l a t e t o t h e p r e s e n c e o r a b s e n c e of a r t e r i a l d i s e a s e s h o u l d
be referred to the medical director of the Field Center
or t o h i s o n - s i t e
r e p r e s e n t a t i v e .I n f o r m a t i o n
t o be g i v e n t o t h e p a r t i c i p a n t o r h i s / h e r
p h y s i c i a n is d e s c r i b e di nM a n u a l 2.
7.2
P a r t i c i p a n t Apparel
T h eu l t r a s o u n dc o m p o n e n t
of t h i s e x a m i n a t i o n r e q u i r e s e a s y
access t o t h e s k i n
o v e r l y i n g a r t e r i e s i nt h en e c k .P a r t i c i p a n t s
wear loose f i t t i n g a p p a r e l
p r o v i d e db y each f i e l d c e n t e r . J e w e l r y p r e s e n t o n
t h e h e a da n dn e c k ,
i n c l u d i n g gold c h a i n s ,n e c k l a c e sa n d
e a r r i n g s , i s removed p r i o r t o s c a n n i n g .
7.3
S t uPdrye l i m i n a r i e s
7.3.1
IBM-XT Computer
The order i n w h i c h t h e
blood pressure equipment is t u r n e d o n is c r i t i c a l t o
t h es u c c e s s f u lf u n c t i o n i n g
of t h ec o m p u t e rs y s t e m .T h eD i n a m a p
is f i r s t
t u r n e d on. I t i s e s s e n t i a l t h a t t h e Dinamap be i n Manual Mode a t a l l times.
The IBM XT computer i s t h e n t u r n e d o n .
A f t e r r e c e i v i n g replies t o p r o m p t s f o r d a t e and time c o r r e c t i o n , t h e IBM XT
c o m p u t e rd i s p l a y s a c:\> p r o m p t .T h es o n o g r a p h e rt h e nt y p e s
t h e command:
GETBP on t h e IBM XT k e y b o a r da n dp r e s s e s
t h e ENTER key.
T h e c o m p u t e r prompts
t h es o n o g r a p h e rf o r
t h e p a r t i c i p a n t I D n u m b e rb yd i s p l a y i n gt h ef o l l o w i n g :
ENTER PARTICIPANT I D :
ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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V i s i t 3 VERSION 3.0 0 1 / 9 5
37
The sonographer then enters the field center letter, followed
the by
participant ID number and presses ENTER. If a file for that participant
already exists, the monitor will display the message:
X12345
ALREADY
EXISTS. YOU
DO WISH TO OVERWRITE
The computer program is not designed to save more
one than
fileon any
participant. If the response entered by the sonographer "n",
is the program
automatically ends and returns the computer
to the DOSprompt. If the
response entered is
'*y" or any other key except
"n'*, the existing file will
overwritten bythe file being created during
this study.
After the participant ID number has been accepted by both
computer, the IBM XT computer monitor will display
the message:
Ready to take blood
7.3.2
sonographer
be
and
pressure
486 Computer
To initiate the ultrasound study flow program,
type aricscan at the
C:\>
prompt and press ENTER. The date appears. If it is correct, press the ENTER
the ENTER key.
key. If the date is incorrect, type the correct date and press
After pressing the ENTER key, the time appears. Verify or correct it as
instructed aboveand-press the ENTER key. After pressing
the ENTER key, ARIC
STUDY appears, very quickly followed by the VERSION screen. Press the ENTER
key. The computer screen will read
"MOUNT TAPE AND MOUNT DISK B DRIVE. ENTER
WHEN
READY
."
The ENTER key is pressed after completing each on
field
the screen. When the
sonographer enters information on the screen, he/she may move
to make
back
corrections by using the arrow keys on the keyboard.
7.4
Preliminary
Questionnaire
The operator completes the questionnaire as follows.
The 486 computer screen
will read:
PUT TAPE IN THE PHASE 2 VCR and PUT ( 3 1/2") DISK
IN
DRIVE
B e
Follow the instructions, placing asVHS videotape cassette in the
VCR, and a
previously formatted 3 1/2" diskette. Press the ENTER key.
After pressing the ENTER key, a WAIT
setting upto record on the tape.
message
appears
while
the
2 is Phase
Wait until the Demographic screen appears. One by one, the field requiring
information to be supplied by the sonographer will be highlighted in yellow.
For example, when the Patientis ID
yellow, the sonographer would then
type in
the participant's ID number, followed by the ENTER key. Note that
the field
center (first) character is inserted automatically. Ifthe ID'S do not match,
the sonographer should determine which computer the
has wrongID. Then, exit
the programon that computerand re-initiate the program,and enter theID
correctly.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
Visit 3 VERSION 3.0 01/95
38
Type the Visit Code, using
two digits, and pressthe ENTERkey. Type the
Sonographer ID, using three digits, and press the ENTER key. Verify
the
Cassette ID and press the ENTER key. The Cassette ID is automatically
assigned by the computer program. Type participant's initials, last name,
gender, race and date of birth,,pressing the ENTER key after each entry.
When all fields have been filled in EVERYTHING CORRECT? appears
on the lower
portion of the screen. Answer N or Y. N signifies that an error was made in
the demographic entries. Y signifies that everything is correct. Ifthe
choice madeis Y, a wait screen appears while the VCRup sets
to begin
recording. (Do not press the ENTER key while the WAIT screen is visible.)
If the choice is
N, the demographics screen appears again, and incorrect
entries are re-typed. (See above). After the last entry, VERIFY appears
again. Type Y if all is correct: if not, type
N and loop through this process
once more.
Information from this questionnaire is entered the
intofield center computer.
This information will be sent
to the reading center
on a diskette under the
participant's .DEM file.
7.5
Blood Pressure
7.5.1
Applying the Blood Pressure Cuffto the Ankle
If the date is
an even number, place the cuff on the left ifankle;
the date
is an odd number, place the cuff on the right ankle. Apply the ankle blood
pressure cuff to the lower extremity selected. (Socks or stocking have been
removed, or moved below
the ankle to keep participant's
the
foot and/or toes
warm if the room iscool). Where practical, use the same cuff forthe ankle
as for seated blood pressure. This information is found the
in participant's
chart. If the participant's ankle is very large and/or strongly tapered,
a
larger cuff may be necessary.
While ankle blood pressures are obtained, the participant shoulda be in
supine position without any pillows or support the
underlegs, unless this
causes discomfort. In most cases the participant will be comfortable in that
position for the short time neededto take the ankle blood pressure. Ifa
participant feels that a pillow is necessary, provide one and indicate
on the
log sheetthat a pillow was
used during ankle blood pressure.
Proper application of
the appropriate cuff above the ankle
of the selected leg
is shown in Figure
20 or 21. Lay the cuff flat on the table (the surface
marked "side to the patient" face up) with the ankle centered on the cuff.
For the moment, disregard the "over the artery" marker.
The lower edge of the
cuff, from whichthe tubes extend,
should be approximately2 to 2 1/2 inches
above the medial malleolus. Following the contour the
of lower leg, wrap the
end of the cuff with
the Velcro fastener over the ankle,
as shown in Figure
20
or 21. Note that dependingon the degree of tapering this
in
area, the cuff
corner willbe offset from parallel toward the knee.
Holding the cuff from sliding, wrap the other endthe
over
ankle as shown in
of the ankle, and
step I11 in Figure 20 or 21, again following the contour
secure the Velcro fastener. Check to be sure that the corners of the Cuff
extending above the upper edge of the cuff are about equal.
If one end
extends morethan the other,
loosen the Velcro and adjust
the wrap.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
39
Next, locatethe "over the artery" marker of the cuff, and rotate the
so cuff
that this line is directly over the posterior tibial artery.
The cuff may be.
rotated more easily by sliding it toward the malleolus, and after alignment,
the cuff can be made snug by pulling it up toward the calf. The cuff should
conform closelyto the shapeof the ankle, with
the lower edge 1 to 2 112
inches abovethe malleolus.
.*
The posterior tibial artery is usually palpated as it courses posteriorly
to
the medial malleolus. Even if the posterior tibial pulse is not palpable, the
posterior tibial artery is used as the location for the marker
on the
line
cuff for the "over the artery
position". Any kinks in the tubing are removed,
and tension on the tubing on the participant's leg is relieved. If needed,
masking tapeor hospital clips are applied this
at
timeto anchor the tubing
to the ultrasound table
to maintain this position.
Explain the blood pressure measurement procedure
theascuff is put into
place. Be sureto explain that repeated blood pressure measurements
will be
obtained automatically. Advise the participant that the first inflation is
always somewhat uncomfortable due to lack of "individualized" adjustment by
the machineto that particular person's blood pressure. Subsequent readings
require a lower pressure and will cause less discomfort.
If an adequate systolic blood pressure measurement is not obtained
the
at
ankle, verify that the cuff has been wrapped appropriately and has not
slipped. If upon inflationthe cuff rolls down toward the foot, the cuff
a larger
should be reapplied more snugly. If the cuff unwraps upon inflation,
cuff may be substituted. If a cuff is rewrapped or changed, an additional
manually-triggered BP is taken.
Observe the participant for a tendency to "stretch" the calf or wiggle the
foot during the blood pressure reading. If it occurs, discuss the effect of
this action with the participant before the ultrasound scan is started,
stressing the need for the leg and arm to be kept still
the blood
during
pressure readings. Discomfort during the blood pressure measurement may
indicate thatthe ankle cuff has been applied
too tight,not applied smoothly,
or that it is
too narrow.
Once the ankle blood pressure is completed the cuff is removed
the ankle.
from
The participant's sock and/or blanket is replaced
to make the participant
comfortable asthe blood pressure procedures move
to the arm.
7.5.2
Applying the Blood Pressure Cuff
to the Arm
Proper size of the cuff is essential for accurate blood pressure measurementsmall adult, adult,
Field Centers have four standardized cuffs available
large adult, and thigh cuff. The same standardized
cuff Sizes are used for
sitting blood pressure and for the measurement of postural changes in
Ultrasound blood pressure.
-
Use the cuff size used the
for sitting blood pressure measurements, (recorded
on the Itinerary Form) for selecting the .of
size
the Dinamap cuff for
the
upper extremity. The standard cuffs provided are by the Baum Company
for the
sitting blood pressure, and by Dinamap for the blood pressure measurements
the Ultrasound work station.
ARIC PROTOCOL
6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
at
40
Once t h e p a r t i c i p a n t i s g i v e n i n s t r u c t i o n s a n d e x p l a n a t i o n s , a n d t h e e q u i p m e n t
h a sb e e nc h e c k e d ,b l o o dp r e s s u r em e a s u r e m e n tb e g i n s .
The f o l l o w i n g steps must
be f o l l o w e d p r e c i s e l y .
1.
I f t h e p a r t i c i p a n ti n d i c a t e s
t h a t there is a m e d i c a l or p o s t - s u r g i c a l
arm, o r
reasonfornothavingthebloodpressuremeasuredontheright
iftheright
arm i s m i s s i n g , p r o c e e d w i t h t h e l e f t
arm. I n d i c a t e on
t h e I t i n e r a r y Form and on a Note Log t h a t t h e l e f t arm is u s e d .
If i n
t o h a v e a blood p r e s s u r e t a k e n
doubt, or i f t h e p a r t i c i p a n t p r e f e r s n o t
on e i t h e r arm, t h e s o n o g r a p h e r s h o u l d c o n s u l t w i t h t h e i r i m m e d i a t e
supervisor.
2.
I ft h e arm c i r c u m f e r e n c eh a sn o t
been measured .at t h eS i t t i n g Blood
Pressurestation,havetheparticipantstandfacing
awayfrom t h e
arm b e n t 90 d e g r e e s ' a t t h e elbow, handon
observer with the right
( a t t h e t o p o u t e re d g eo f
m i d s e c t i o n . Locate t h e t i p o ft h ea c r o m i o n ,
t h e s h o u l d e r b l a d e ) andmeasure t h e l e n g t h of t h e u p p e r arm from
Mark t h e
acromion t o t i p o f elbow u s i n g a c e n t i m e t e r t a p e m e a s u r e .
arm a n d t h e n h a v e t h e p a r t i c i p a n t r e l a x t h e
arm a t
midway p o i n t o f t h e
t h e side. Wrap t h e t a p e a r o u n d t h e
arm o v e r the midpointmark,making
is l e v e l .M e a s u r et h e
arm c i r c u m f e r e n c e t o t h e
surethatthetape
record. See Table 1. below:
n e a r e s t1 / 2c e n t i m e t e ra n d
T h er a n g em a r k i n g so nc o m m e r c i a lc u f f so v e r l a p
from s i z e t o s i z e a n d d o n o t
AFUC S t u d y arm s i z e i s m e a s u r e d , a n d t h e
o f f e r a precise g u i d e l i n e . I n t h e
c u f f s i z e i s selected a s follows:
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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V i s i t 3 VERSION 3.0 01/95
41
Table 1.
Determination of cuff size based on arm circumference
Cuff Size
Arm
Circumference
<
24
cm
to 32
cm
3 3 to 4 1
cm
Small Adult
Adult
Large
Adult
24
>
Thigh
The
ultrasound
of the
part
exam
41
cm
begins.
Before activating the
next phase of the study,
take a minute
to instruct the
participant on the "noconversation" rule. Also, remind the participant to
"hold questions" about exam results until after the last portion
the
of
ultrasound station exam is completed, since it is important that all
participants be "treated the same way".
7.5.3
.
Blood Pressure Examination
Instructions to position the cuff and to take manual ankle pressure will
appear on the ultrasound computer monitor. The computer monitors will display
the following messages:
.
4 8 6 DELL/CSA
MANUAL ANKLE
Monitor
blood
.
..:
pressure
'
IBM Monitor
Ready,to take blood
.
pressure'.
.
. .
Press M on the IBM keyboard.
When
yellow
light stays
cuff
press Y and ENTER on DELL/CSA
keyboard
off,
. .
.
.
P
Press M on the IBM
keyboard.
If an adequate systolic blood pressure measurement is not obtained
the
at
ankle, the sonographer verifies that the cuff has been wrapped appropriately
and has not slipped. If upon inflation the cuff
rolls downtoward the foot,
the cuff should be reapplied more snugly. If the cuff unwraps upon inflation,
a larger cuff may be substituted. If
a cuff is rewrapped or changed,
an
additional manually-triggered BP is taken.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
42
IBM ComputerMonitor
4 8 6 ComputerMonitor
Ready t o t a k e b l o o d p r e s s u r e
MAMJAL ANKLE b l o o d p r e s s u r e
Press M on t h e IBM keyboard.
When y e l l o w c u f f l i g h t
Received command t o t a k e manualbp
T h i s w i l l c a l i b r a t e t h e dinamap
stays o f f ,
p r e s s Y and ENTER on DELL/CSA
kevboard
A f t e r t h e manual blood pressure
. .
.
.
..
. ..
..
i s t a k e n t h e s c r e e n s w i l l read:
.
.
IBM CombutetMonitor
486 Computer Monitor
Ready t o t a k e b l o o d p r e s s u r e
MANUAL ANKLE b l o o d p r e s s u r e
Press M on t h e IBM keyboard.
When y e l l o w c u f f l i g h t
Received command t o t a k e manualbp
T h i s w i l l c a l i b r a t e t h e dinamap
stays o f f ,
p r e s s , Y a n d ENTER on DELL/CSA
keyboard
Ready t o t a k e b l o o d p r e s s u r e
Press Y and ENTER on t h e 4 8 6 computerkeyboard.
4 8 6 Computer Monitor
COMPUTER ANKLE
I
IBM Computer Monitor
Ready t o t a k e b l o o d p r e s s u r e .
P r e s s A on t h e IBM keyboard.
When y e l l o w c u f f l i g h t
stays off,
p r e s s Y and ENTER on DELL/CSA
keyboard
Received..command t o t a k e manualbp
T h i s w i l l c a l i b r a t e t h e dinamap:.
I.I
. ..
..
.. .
Readv- to t a k e b l o o d D r e s s u r e
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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V i s i t 3 VERSION 3.0 01/95
43
Press A and ENTER on
. ..
the
IBM
kevboard.
.. .
. .
Received command to take manualbp
This will calibrate the dinamap
COMPUTER ANKLE
.
Computer Monitor
IBM
486 ComputerMonitor
P r e s s A on t h e IBM keyboard.
Ready to take
blood
pressure
When yellow c u f f l i g h t s t a y s o f f ,
Received command t o t a k e a n k l e b p
press',Y and ENTER on DELL/CSA
keyboard
After the data has been collected,
a copy of the data sent
to the IBM will be
copied onto the IBM monitor. The data displayed will look something like
this:
IBM
486 ComputerMonitor
.
. .
.
.
. .
Computer Monitor
.
'
Received command to take manualbp
This will calibrate the dinamap
COMPUTER ANKLE
; , P r e s s A on t h e IBM keyboard.
...
Ready
.When
. .
yellow cuff light stays
to
take
blood
pressure
off,
Received
p r e s s .Y and ENTER on DELL/CSA
keyboard
A 12:33.50
command to take
anklebp
BBA13053400130533093082132068
After the ankle blood pressure is taken and the cuff is fully deflated, the
IBM screen will read:
..
486 Computer Monitor
...
'. COMPUTER
IBM Computer Monitor
ANKLE
Received
command to take
anklebp
P r e s s A on t h e IBM keyboard.
. .
Whim yellow c u f f l i g h t s t a y s
off,
A 12:33.50 BBA13053400130533093082132068
press Y and ENTER on DELL/CSA
keyboard
Ready t o t a k e b l o o d p r e s s u r e
The cuff is removed fromthe ankle. See Section 7.5.2 for arm cuff
application.
ARIC PROTOCOL
6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
44
Press Y and ENTER o n t h e 486 computerkeyboard.
thenread:
The computermonitors
will
IBM . Computer Monitor
4 8 6 ComputerMonitor
MANUAL ARM
Received command t o t a k e a n k l e b p
P r e s s M on t h e IBM keyboard.
A 12:33.50~BBA13053400130533093082132068
When y e l l o w c u f f l i g h t s t a y s o f f ,
Ready t o t a k e b l o o d p r e s s u r e
press Y and ENTER on DELL/CSA
keyboard
Press M on t h e IBM k e y b o a r d .S h o r t l ya f t e r
M i s p r e s s e d on t h e IBM keyboard,
t h e IBM computer w i l l append t h e f o l l o w i n g messageon t h e s c r e e n :
IBM Computer Monitor
4 8 6 Computer Monitor
Received command t o t a k e a n k l e bp
MANUAL ARM
i
P r e s s M on t h e IBM keyboard.
A 12:33.50
When'yellowcufflightstaysoff,
Ready t o t a k e b l o o d p r e s s u r e
" p r e s s Y.and ENTER on DELL/CSA
keyboard'
T h i s w i l l c a l i b r a t e t h e dinamap
After the
..
/I'
,:
,
manualbloodpressure
4 8 6 Computer .Monitor
MANUAL ARM
P r e s s M on t h e IBM keyboard.
BBA13053400130533093082132068
Received command t o t a k e manualbp
i s t a k e n , t h e IBM s c r e e n w i l l read:
I
IBM Computer Monitor
Ready t o t a k e b l o o d p r e s s u r e
Received command t o t a k e manualbp
T h i s w i l l c a l i b r a t e t h e dinamap
When y e l l o w c u f f l i g h t s t a y s o f f ,
..
. .
' p r e s s Y and ENTER on DELL/CSA
Ready t o t a k e b l o o d pressure
keyboard
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
- Visit
3 VERSION 3.0 01/95
45
Press Y and ENTER 4 8 6 computerkeyboard.
IBM Computer Monitor
4 8 6 Computer Monitor
Ready t o t a k e blood pressure
COMPUTER ARM
Press B on t h e IBM keyboard.
Received- command t o t a k e manual bp
T h i s w i l l c a l i b r a t e t h e dinamap
To CONTINUE
p r e s s Y and ENTER on DELL/CSA
keyboard
Ready t o t a k e b l o o d p r e s s u r e
Press B and ENTER on t h e IBM keyboard.
4 8 6 Computer Monitor
1'
COMPUTER ARM
.
Press B on t h e IBM keyboard.
I
IBM Computer Monitor
Ready
bt p
a
l ok
r te
oeosds u r e
Received command t o t a k e manual bp
T h i s w i l l c a l i b r a t e t h e dinamap
To CONTINUE:
.
Ready t o t a k e blood pressure
.
p r e s s Y and ENTER on DELL/CSA
keyboard
Received command t o t a k e arm bp
Press Y and ENTER on t h e 4 8 6 computerkeyboard
to continue.
A f t e r t h e d a t a h a s been c o l l e c t e d , a copy of t h e d a t a s e n t t o t h e IBM w i l l be
copiedonto t h e I B M monitor. The datadisplayed w i l l looksomething l i k e
this:
4 8 6 Computer Monitor
.COMPUTER ARM
IBM Computer Monitor
Received command t o t a k e manualbp
T h i s w i l l c a l i b r a t e t h e dinamap
Pres's B on t h e IBM keyboard.
Ready t o t a k e blood pressure
To CONTINLIE
Received command t o t a k e arm bp
p r e s s Y and ENTER on DELL/CSA
keyboard
B 12:33.50
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
BBA1305340013053309308~132068
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V i s i t 3 VERSION 3.0 0 1 / 9 5
46
After the arm blood pressure is taken and the cuff is fully deflated,
the IBM
screen will read:
486
.
Computer
IBM Computer
Monitor
This
COMPUTER ARM
.
Press B on the IBM keyboard.
. .
will
calibrate
the
Ready to
takeblood
Received
commandto take
Monitor
dinamap
pressure
.
TO.CONTINUE
' p r e s s Y and
ENTERon DELL/CSA
armbp
B 12:33.50 BBA13053400130533093082132068
keyboard
Ready to take
blood
pressure
Arm blood pressures will be taken intermittently during ultrasound. The
CSA/Dell will prompt the sonographer for BP initiation.
At the endof the study, the program is automatically exited.
The program
creates a file containing the recorded blood pressures, which is placed
"studies" directory. The file is named with the participant ID the
as file
name and bpas its extension,
i.e., X******.bp, where X represents the field
center code, and the asterisks represent the participant ID number.
in
At the conclusion of the examination, the sonographer copies the blood
pressures files onto
a floppy diskette along with
the other participant files,
and sends the diskette along with the videotape
to the Ultrasound Reading
Center.
7.6
Preparation for ultrasound Examination
The subject is in
a supine position with his/her legs resting comfortably
on a
pillow. The participant's position should allow head rotation
to either side.
The sonographer is seated at the end of the exam table that is nearer the
participant's head. The top of the
participant's head is about one to three
inches fromthe end of the exam table,so as to afford easy access
to the
sonographer of the areas
of the neck to be scanned.
When the 486 computer screen reads:
Insert Tape and
Diskette
and
Press
ENTER
when ready
Insert tape and diskette, and press ENTER. 486
The computer screen will read:
Press Record
Press RECORD on Sonographer Box. The NEC PC-VCR is automatically placed in
the RECORD mode by the computer.
A red circle on theVCR front panel
indicates that this VCR is recording.
A study code flow screen will appear
on the 486
monitor. The text will be
color coded as follows:
Yellow highlight indicates that
a code is to scanned.
be
Pink highlight indicates thata code is
to be scanned next..
-
ARIC PROTOCOL 6a. Ultrasound Scanning ProceduresVisit 3 VERSION 3.0 01/95
the
47
Green h i g h l i g h t i n d i c a t e s t h a t
The 486 computerscreen
looks l i k e t h i s :
a codehas
been scanned.
PRESS RECORD TO START
I1
IBM Computer Monitor
4 8 6 ComputerMonitor
***
screen, which
w i l l now d i s p l a y t h e f i r s t s c a n n i n g
***
012
Start Code/Calibration
048
R i g h t Common Optimal
080
RightBulbOptimal
112
R i g hItn t e r n a l
084
RightBulbFar
092
R i g h t B u l b Near
Ready t o t a k e b l o o d ' p r e s s u r e
..
Receivea .command t o t a k e arm bp
,
..
B 12: 33.50 BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
The 486 computer i s now r e a d y f o r t h e s t a n d a r d p r o c e d u r e f o r
a B-mode
u l t r a s o u n d scan of t h e r i g h t s i d e . I n s t r u c t i o n s f o r s c a n n i n g t h e r i g h t s i d e
are d i s c u s s e d i n S e c t i o n 8 . 2 .
fter t h e r i a h t s c a n ,
h e computer monitors
which may o r may n o t i n c l u d e
w i l l read:
4 8 6 ComputerMonitor
..
COMPUTER ARM
.
.
Q C s , hasbeencompleted,
IBM Computer Monitor
'
Ready t o t a k e " b 1 o o d ; ' p r e s s u r. e.
. . . .
.
. .
.. .
. .
Press B on t h e IBM keyboard.
Received. command .to t a k e arm bp
To CONTINUE
B. 12 :33.50 BBA13053400130533093082132068
p r e s s Y and ENTER on DELL/CSA
keyboard
Ready t o t a k e b l o o d p r e s s u r e
'
. '
:.
Press B on t h e I B M kevboard.
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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486 ComputerMonitor
.
IBM ComputerMonitor
Received command t o t a k e arm bp
COMPUTER ARM
P r e s s B on t h e IBM keyboard.
B 12:33.50
BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
To CONTINUE
p r e s s Y and ENTER on DELL/CSA
keyboard
Received command to t a k e arm bp
A f t e r t h e d a t a h a s been c o l l e c t e d , a copy of t h e d a t a s e n t t o t h e IBM w i l l b e
c o p i e d o n t o t h e IBM monitor.
486 ComputerMonitor
B 12:33.50
COMPUTER ARM
P r e s s B on t h e IBM keyboard.
BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
Received command t o t a k e arm bp
To CONTINUE
p r e s s Y and ENTER
keyboard
IBM Comnuter Monitor
on
DELL/CSA
A f t e r t h e arm b l o o d p r e s s u r e
screen w i l l r e a d :
B 12:33.50
BBA13053400130533093082132068
is t a k e n and t h e c u f f i s f u l l y d e f l a t e d , t h e
4 8 6 ComputerMonitor
COMPUTER ARM
P r e s s B on t h e IBM keyboard.
To CONTINUE
p r e s s Y and ENTER on DELL/CSA
keyboard
B 12:33.50
IBM
IBM ComputerMonitor
BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
Received command t o t a k e arm bp
B 12:33.50
BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
ARIC PROTOCOL 6a. UltrasoundScanningProcedures
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49
P r e s s Y and ENTER o nt h e 4 8 6 computerkevboarq.
-The l e f t side menu 8creen
w i l l a p p e a r on t h e 486 monitorand w i l l look l i k e t h i s :
.
-
IBM Computer
Monitor
486 ComputerMonitor
032
L e f t Common Optimal
064
L e f t B u l b Optimal
096
L e fIt n t e r n a l
068
L e f tB u l b
Far
076
L e f tB u l b
Near
B 12:33.50
'
.
'
BBA13053400130533093082132068
After t h e s c a n of t h e l e f t s i d e h a s b e e n c o m p l e t e d . T h e m e s s a g e s o n t h e
c o m p u t e rs c r e e n s w i l l read as f o l l o w s :
486 ComputerMonitor
SITTING p r e s s u r e
Press
S
on t h e IBM keyboard.
When y e l l o w c u f f l i g h t s t a y s
off,
press Y a n d ENTER on D e l l / C S A
keyboard
.F
B 12 :33'.50 BBA13053400130533093082132068~
-
The s o n o g r a p h e r e x p l a i n s t o t h e p a r t i c i p a n t t h a t s i t t i n g a n d s t a n d i n g b l o o d
p r e s s u r e s w i l l now b et a k e n .
The s o n o g r a p h e r s h o u l d i n s t r u c t t h e
participant
to rest q u i e t l y d u r i n g t h e s e b l o o d
pressures and assist t h e p a r t i c i p a n t t o
t h e s ep o s i t i o n sw i t h
as little movement a s possible. F o l l o w i n gt h e s e
guidelines,thesonographerthenaskstheparticipant
t o sit.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
- Visit
3 VERSION 3.0 0 1 / 9 5
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Press S on t h e IBM keyboard.
486 Computer Monitor
The IBM screen w i l l read:
I
IBM Computer Monitor
Ready t o t a k e blood p r e s s u r e
Received command t o t a k e arm bp
B 12:33.50 BBA13053400130533093082132068
Ready t o t a k e blood p r e s s u r e
Received command t o take s i t t i n g bp a f t e r 30 sec.
The IBM computer w i l l automatically wait t h e 30 seconds required before taking seated
i n t h e protocol.After
t h e d a t a h a s been c o l l e c t e d , a copy
bloodpressure,asrequired
of t h e d a t a s e n t t o t h e IBM w i l l becopiedonto
t h e IBM monitor.
T h e data displayed w i l l
looksomething l i k e t h i s :
A f t e r t h e seated blood pressure
w i l l read:
.. . ... .. . .. ....
.... ..........
.: .
.. . .
.. ................. '.'.::,'":'488~''6~
iter udnitor
.. . .
......
..... . ..
.. ....
.
......
.
.
. . . . . . . .
...
. . .. . . . SITTING p r e s s u r e
..... .. ........ .... .... . :,.:..
... .... .. . .. . .. ...
... .. . .
... ... . .. .. .. . . . . . .
.:
is taken and t h e cuff i s f u l l y d e f l a t e d ,
t h e IBM screen
IBM Computer Monitor
Ready t o t a k e blood p r e s s u r e
. . . ... .. .. .
Pres;k
the
.. ..S ..on.'
..... ..... .... ... . . .. . .
.
. . . . .
. .
... ... . . . ... . . . .
. ...
.. .... . .. :. . ,. .: ,
.
......
When..yellow'.
.. ..
; ;.. ' . .
. . .
#,.,:, . . . . .
.'
;ore-".
c
11 p r e s s ' Y 'and
.
keyboard.
...
.
u
f
'
IBM keyboard.
Received command t o t a k e s i t t i n g
bp a f t e r 30 sec.
.
S 12:33.50 BBA13053400130533093082132068
f
'
f i g h t sst taayyss
ENTER on Dell/CSA
Ready t o t a k e blood p r e s s u r e
..
...
... .. .. .. .. . . . ..
,
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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Press Y and ENTER on the
486 c o m w t e r keyboard.
IBM .Computer
486 Computer Monitor
First STANDING
The 486 screen will now read:
Ready t o take
blood
Monitor
pressure
pressure
Received command.to
Press T on the IBM keyboard.
take.sitting
bp after 30 sec.
. .
S 12:33.50~BBA13053400130533093082132068
When yellow cuff light stays
off,
press Y and ENTER on Dell/CSA
keyboard
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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3 VERSION 3.0 01/95
52
The
the
ha8
IBM
IBM computer will automatically
wait the 30 seconds required before taking
first standing blood pressure,a s required in the protocol. After the data
been collected,a copy of the data
sent to the IBM will be copied onto the
monitor. The data displayed will look something like
this:
After the first standing pressure
is taken and the cuff is fully deflated, the
IBM screen willread:
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
Visit 3 VERSION 3.0 01/95
53
Press Y and ENTER on
486 Computer
the
486
compul
m.
The
486 screen will now read:
IBM Computer Monitor
Monitor
. .
A SECOND
will
be
STANDING pressure
taken after
20 seconds
v.
When yellow cufflight stays off,
press Y and ENTER on Dell/CSA
keyboard
Ready t o take
.blood
pressure
...
.
Received command to
after 30 sec.
.
.
takefirst standing b p
.
.
'
..
T : 12 :33.50 BBA13053400130533093082132068
A second.standing bp will taken in.twenty
The second standing blood
dictated by the protocol.
. .. . ... .. ...... ... ....... ..... ... ..
................
......
.............
...............
.. . ....... ... .. ... . . . . "f486'Computer
.
.. ...... ......... .... ..... .. ... .. ...
. . ,.' ..
..;.,..:.:
..;:..... .. . .. .. .'::...
STANDING
. . A,'
. ,
..
.. ,.
...............
........
wili
be
taken
sicom
pressure will be taken
The IBM will read:
IBM Computer
Monitor
pre.ssure
after
20 seconds
automatically
at the
Received command to
after 30 sec.
timeinterval
Monitor
takefirst standing bp
T 12:33.50 BBA13053400130533093082132068
A second standing bp will taken in twenty
seconds
Ready to
take
blood
pressure
Received command t o take
After the
data
has
been
collected,
a copy of the
data
-
sent
second
to
standingbp
the
IBM will
be copied
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
54
Left Leg
Fabric
Velcro
"Ears"
about
equal
Medial
malleous
Figure 20.
Blood Pressure Cuff Placement
- Left Ankle
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
55
Right Leg
Fabr
on
"Ears"
about
equal
Medial
malleous
Figure 21
Blood Pressure
Cuff Placement
-
Right Ankle
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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V i s i t 3 VERSION 3 . 0 01/95
56
CAROTID
8.
SCANS
Orientation of theparticipant's head as follows. The participant is asked t o
look straight up at the ceiling. A triangular shaped, firm foam rubber wedge
shaped in a 45-45-90 degree form is used position
to
the head in a standard
way.
The wedge is placed on the examination table, with largest surface of
the wedge facing down. It
is placed on the examination table
next to the
side of the neck to be evaluated in a such
way that the 90Y angle is furthest
from the midline of theface. This positions the45# angle closest t o
midline. The wedge is then gently
pushed toward the midline of the
head until
the 45# angle edge touches thescalp. The participant i s then asked t o rotate
his head toward the foam rubber wedge
until the side of the head just above
the ear rests againstit. The chin may be raised slightly and the shoulder
adjusted slightly for bettervisualization. The ultrasound equipment is
positioned so that the sonographer has
access to the participant's neck, all
instrument controls and foot pedals.
8.1
Calibration
A calibration is done before each scan.
followed
in
ordert o standardize
the
The following settings must be
calibration
procedure.
The Phase 2 settings should beas follows:
the gain is set at 5 0 % ,
the TGC is in a stair step alignment
the focus is in the mid focus setting (2cm)
The
transducer
motor
is and
on there should
not be
any gel
on
the
transducer.
The monitor displays will read follows:
as
486
***
Computer
Monitor
PRESS RECORD TO START
.
. .
...
..
***
Ready to
.
.
..
.
IBM. Computer
.
. .. ..
.
Monitor
:'
'
..
take.blood pressure
012 Start Code/Calibration
Received command to
048
Right Common Optimal
080
Right Bulb Optimal
112
Right Internal
takearm bp-,
B 12 :3 3 . 5 0 BBA13053400130533093082132068
..
. .
Ready to take blood pressure
.
084
Right Bulb Far
092 Right Bulb Near
..
.
.
.
.
.
.
I
Verify that 012 Start Code/Calibration
is highlighted in yellow. TO mark this
and each following site, choose SELECT by using the SELECT footswitch. The
SELECT messagewill. appear on the flow screen
for approximately 10 seconds.
After pressing SELECTfootswitch, wait for 7 seconds, then press NEXT SITE
footswitch t o move to thenext site to bescanned. The yellow highlight moves
to the next code, and the previous codeis highlighted in green. "Do
Preliminary Scan Now Press N e x t Site Footswitchwhen finished" appears on
screen of the
CSA/Dell.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 0 1 / 9 5
1
57
8.2
RigC
h ta r o t S
i dc a n
neck a r e p o s i t i o n e d f o r t h e
exam o f t h e r i g h t c a r o t i d . T h e
foam
Theheadand
is r o t a t e d
r u b b e r wedge i s p l a c e d o n p a r t i c i p a n t ' s l e f t s i d e , a n d t h e h e a d
t o w a r d t h e foamrubber a s o u t l i n e d i n t h e i n t r o d u c t i o n
to this section.
8.2.1
Preliminary
t h e common c a r o t i d a r t e r y i s p e r f o r m e d w i t h t h e p a t i e n t
as shown i n F i g u r e 26.The
h e a dp o s i t i o na n dt r a n s d u c e ri n t e r r o g a t i o na n g l e
scan i s t o l e a r n t h e a r t e r i a l geometryand
p u r p o s e of t h i s p o r t i o n o f t h e
orientationoftheparticipant.Usingfinetransducerangulationstoclearly
displaytheblood-intimaboundarieswithin
the vessel,thetransducer
is
s l o w l y moved t o w a r d t h e m a n d i b l e u n t i l t h e w i d e n i n g o f t h e c a r o t i d b u l b , a n d
f i n a l l y t h e i n t e r n a l a n de x t e r n a lc a r o t i d
arteries, are v i s u a l i z e d . U s i n g t h e
knowledgeoftherelativeorientationoftheinternalandexternalcarotids
from t h i s s c a n , t h e o p t i m a l a n g l e w h i c h s h o u l d b e s t d i s p l a y t h e
t i p of t h e
i n F i g u r e s 22-25.The
f l o w d i v i d e r may b ed e t e r m i n e du s i n gt h ed i a g r a m s
i s now s c a n n e d l o n g i t u d i n a l l y a t t h i s
entirelengthofeachcarotidsystem
oDtimal i n t e r r o u a t i o n a n u l e t o p r o v i d e a n o v e r a l l q u a l i t a t i v e i m p r e s s i o n
of
theextentandseverityofdiseaseandthequalityoftheimage
at this
or p o s s i b l el e s i o n s a r e
i n t e r r o g a t i o na n g l e .U n u s u a la n a t o m i cf e a t u r e s
o b s e r v e d . O r a l comments are r e c o r d e dd u r i n gt h ee x p l o r a t o r ys c a n
t o assist
the reader during the reading process.
A transverse scan of
8.2.4Thecursor
i s p l a c e di nt h e" D o p p l e r "
mode o nt h eB i o s o u n di n s t r u m e n t
p a n e l . The s o n o g r a p h e rd e t e r m i n e sw h i c ha r t e r y
is t h ei n t e r n a lc a r o t i d
a r t e r y . The c u r s o r i s f i r s t moved i n t o o n e b r a n c h a n d t h e n t h e o t h e r .
Doppler s p e c t r a o n
The Doppler key i s d e p r e s s e d i n o r d e r t o v i e w t h e
i s p r e s s e da g a i n t o s t o p t h e
theBiosoundscreen.TheDopplerkey
d o p p l e r mode u n t i l t h e s o n o g r a p h e r i s r e a d y t o v i e w t h e D o p p l e r
spectra
a g a i n .T h i s
is r e p e a t e di ne a c hb r a n c h .T h ei n t e r n a lc a r o t i da r t e r y
is i d e n t i f i e d , b a s e d o n t h e
c r i t e r i a o u t l i n e di nS e c t i o n6 . 2 . 5 .P r e s s
t h e DOP CUR key t o remove t h eD o p p l e rc u r s o rf r o ms c r e e n .T h e
p r e l i m i n a r y s c a n i s complete.
8.2.5
T o p u tt h ec r o s s h a i rc u r s o r
on t h e t a p e f o r l a n d m a r k i d e n t i f i c a t i o n , d o
t h ef o l l o w i n g :
a.
b.
Press t h e t h i r d menu key t o d i s p l a y t h e C a l c u l a t e menu.
P r e s st h ef i r s t
menu key t od i s p l a yD i s t a n c e
menu.
C.
P r e s st h ef i r s t
menu k e ya g a i nf o r" D i s t a n c e
plus".
The c u r s o r
w i l l appear i nt h eu p p e rp o r t i o no f
t h e screen.
Place c r o s s - h a i r
in posit ion.
t o u s u a lr a n g e( 3 0 - 5 0 % ) ,a n da d j u s t
TGC s e t t i n g s
d .A d j u s tv i d e og a i n
TGC
minimum o n r i g h t ( t o p ) , maximum on
f o ro p t i m a li m a g i n g .
l e f t( b o t t o m )( s t a i r s t e pc o n f i g u r a t i o n ) .
-
8 . 2 . 6T h es o n o g r a p h e rv e r i f i e st h a tt h ec o m p u t e rm o n i t o ri n d i c a t e st h e
COMMON OPTIMAL i s t o b e s c a n n e d .
RIGHT
-
i s moved p r o x i m a l l y ( t o w a r d o r i g i n
heart)
8 . 2 . 7T h eu l t r a s o u n dt r a n s d u c e r
to view the distal centimeter of the right
common c a r o t i d a r t e r y .
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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The cursor is placed in the lumen as described in Section
6.3.2.
The
best possible image
of the right common carotid artery the
in optimal
angle is obtained as outlined
in Section6.1 and 6.2.3.
8.2.8
The sonographer presses the SELECT footswitch and holds
the image for
at least five cardiac cycles, marking the onsite
video tape.
8.2.9
When the sonographer is ready
to image the next site he/she presses
the
NEXT SITE footswitch
or presses the NEXT SITE switch
on the sonographer
box to advance the program
to the next site. Confirm advancement
of
the program by verifyuing that
the next site
to be scanned in
highlighted inyellow.
8.2.10
'
The transducer is moved distally to the bifurcation area. The
cursor Ps placed at the tipof the flow divider (Section
6.3.3).
The arterial interfaces are optimized at this
site and angle.
8.2.11
The computer monitor indicates RIGHT BIFURCATION.
The sonographer
optimizes the arterial interfaces at this site, andthewhen
best
possible image is obtained as outlined in Sections
6.1 and 6.2.4,
presses the SELECT footswitch and holds the image for at least
five cardiac cycles, marking the site
on videotape.
8.2.12
When the sonographer is ready to image the RIGHT INTERNAL CAROTID,
he/she presses the NEXT SITE footswitch or presses
the NEXT SITE
switch on the sonographer
box to advance the programto the next
site.
8.2.13
The transducer is moved distally to the proximal centimeter of the
internal carotid artery.
8.2.14
The computer monitor indicates RIGHT INTERNAL CAROTID. The cursor
is placed into
the correct position at the
tip ofthe flow divider
as discussed in Section
6.3.4.
The sonographer optimizesthe far
wall arterial interfaces. When the best possible image,as
outlined in Sections 6.2.2 and 6.2.5, are obtained,the
sonographer presses the SELECT footswitch and holds the image
at least five cardiac cycles, marking the onsite
video tape.
8.2.15
8.2.16
When the sonographer is ready to image the RIGHT BIFURCATION FAR
WALL, he/she presses the NEXT SITE footswitch
or presses the NEXT
SITE switchon the sonographer box
to advance the program
to the
next site.
The computer monitor indicates RIGHT BIFURCATION FAR WALL, OPTIMAL
The transduceris moved backto the bifurcation areato
obtain an image of the bifurcation at the optimal angle.
The
cursor is placed at the tip of the flow divider 6.3.3).
(Section
The transducer is slowly tilted along the arterial
so axis
that
the far. wall of
the bifurcation becomes vertical the
in centerof
the display screen. The sonographer optimizes the intima-media
interfaces on the far
wall. During this maneuver,the near wall
echoes willdeteriorate. When the far wall interface echoes
at0
optimized, as outlined
in Section 6.2.6.1, the sonographer presses
the SELECT footswitch
and holds the image for at least five
cardiac cycles, marking the site
on video tape.
ANGLE.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
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59
8.2.17
When t h e s o n o g r a p h e r i s ready t o image t h e R I G H T BIFURCATION NEAR
h e / s h e p r e s s e s t h e NEXT SITE f o o t s w i t c h or p r e s s e s t h e NEXT
SITE switchonthesonographer
box t o a d v a n c e t h e p r o g r a m t o t h e
next site.
8.2.ia
Thecomputermonitorshouldindicatethe
R I G H T BIFURCATION NEAR
WALL, OPTIMAL ANGLE.
The t r a n s d u c e r i s s l o w l y t i l t e d a l o n g t h e
arterial axisbacktowardstheoptimalangleandthenbeyond
so
t h a t t h e n e a r w a l l of t h e b i f u r c a t i o n becomes v e r t i c a l i n t h e
center o f t h e d i s p l a y
screen. The c u r s o r is p l a c e d a t t h e t i p of
6.3.3).
The s o n o g r a p h e ro p t i m i z e st h e
t h ef l o wd i v i d e r( S e c t i o n
wall. D u r i n gt h i sm a n e u v e r ,
m e d i a - i n t i m ai n t e r f a c e so nt h en e a r
t h e f a r w a l l e c h o e s w i l l d e t e r i o r a t e . When t h e n e a r wall
i n t e r f a c e e c h o e s a r e o p t i m i z e d , a s o u t l i n e d i n S e c t i o n 6.2.6.2,
thesonographerpresses
t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e
f o r a t l e a s t f i v e cardiac c y c l e s , m a r k i n g t h e
s i t e on v i d e o t a p e .
Thesonographerremovesthetransducerfromtheneckandpressee
t h e NEXT S I T E f o o t s w i t c h .
8.2.19
Thesonographerlooks
a t t h e computer
monitor
t o see i f a s i t e
w i l l be r e p e a t e d o n t h e r i g h t s i d e f o r q u a l i t y a s s u r a n c e p u r p o s e s
(QC s i t e ) . I f no QC s i t e s c a n i s r e q u i r e d o n t h e r i g h t s i d e , t h e
s o n o g r a p h e r p r e s s e s t h e NEXT S I T E f o o t s w i t c h a g a i n .
u,
If a QC s i t e s c a n i s required, t h em o n i t o d
r i s p l a y si, n
red, t h e
and t h e f l o ws c r e e nh i g h l i g h t s
t h e code.
T h e sonographer
QC s i t e andangle;
moves t h e cursor t o t h e
o b t a i n s a n imageofthe
8.2.20
QC s i t e
a p p r o p r i a t el a n d m a r ka n do p t i m i z e st h e
arterial interfaces.
When
t h e best p o s s i b l e image h a s b e e n o b t a i n e d , h e / s h e p r e s s e s t h e
SELECT f o o t s w i t c h a n d h o l d s t h e
image f o r a t l e a s t f i v e cardiac
cycles,markingthe
s i t e on v i d e o t a p e .
8.2.21
T h seo n o g r a p h epr r e s s e s
NEXT S I T E s w i t c h e o
s nt h se o n o g r a p h e r
o r on t h e NEXT SITE f o o t s w i t c h .
8.2.22
The g e l i s wiped
from
t h ep a r t i c i p a n t ' sn e c k a, n dt h eh e a da n d
n e c k are r e p o s i t i o n e d f o r t h e l e f t s i d e scan.
8.2.23
The arm b l o opdr e s s u rsec r e e n
follow directions on the screen
measurement.
w i l l a p p e a r . The s o n o g r a p h esrh o u l d .
t o completebloodpressure
486 ComputerMonitor
COMPUTER ARM
IBM.Computer Monitor
B 12:33.50~~BBA13053400130533093082132068
..
Press B on t h e B
IM keyboard.
Ready t o t a k e b l o o d p r e s s u r e
To
Received command t o ' t a k e arm b p
CONTINUE
Press Y and ENTER on DELL/CSA
box
'
B 12:33.50
BBA13053400130533093082132068
computer.
Ready to t a k e blood p r e s s u r e
ARIC PROTOCOL 6a. UltrasoundScanningProcedures
-
V i s i t 3 VERSION 3.0 01/95
60
lress B on
the IBM computer k e v b o a r L
486 Computer
.
screens
will
now
read:
IBM Computer
Monitor
Monitor
.
. .
. . . . ......
.. .. ... . .
.. .. .. . . . .
Ready to
COMPUTER ARM
.
.
.
take
blood
pressure
.
Pre'ss B.'on the
.. .. ... .. .... .. . .
.......
.. .. . .. . .. . . . .. .
&(.;:i:
The
~
Received command to
IBM keyboard.
takearm bp
B 12:33.50 BBA13053400130533093082132068
CONTINUE
. . . . . . . ..... .
.. ......... ....::
.........
.......
.. .. .:... .. .... ... . ..: .
..........:.:.. .:..>
.........
. .
'Y'Iand..ENTER on DELC/CSA.
.,'Press
..' c.omput,er
.: . .
. ....
. . . . . . ... .. . .
.'.
Ready t o take
blood
pressure
.... .
. . . . . . .....
.. ... ..... .... ... . ... .... ... .. .. . . .
. .
'
Received command to
takearm bD
copy of the data sentt o t h eIBX will
a displayed will look something like
IBM
Received
Comnuter
command to
be
Monitor
takearm
bp
B 12:33.50 BBA13053400130533093082132068
Ready to
take
blood
Received command to
B 12:33.50
After the arm.blood
screen will read:
pressure
is
pressure
take
arm
bp
BBA13053400130533093082132068
taken
and the cuff is fully deflated, theIBM
. .
.......... ... ... .... ...... .. . .. . .. . ..:.
. . .. .. .... . .. . . . .
.................
.:...
. .:.::.':
. . . ..... . .:/.'
. ..............
. . : . 486'Computer wonitor. .....
..... .. .................. .. . .. . . .
.
. .
... ... .... ...... .. .... .. . . .
:.. ..:::?;.
: :.:: COMPUTER
. . . .. .. .. . . .
.. .. . . . ... . .. . . . .. . . .. . .
....... ......... ........ ..... ..... .... .. ... .. . . .
.....
:. . P
.r.e s s :B
: ,on the.
IBM
.keyboard..
.... .. .. ... .... ..... . .. . .
.. . . . .
"To.:..
. . . CONTINUE
. . .. .. .. . . .. . . . .
. . ... .. . . . .. . . . . . .
. . . . . . . . . . . .. .
..'.
;
IBM Computer
...
B 12:33.50
Ready to
Monitor
BBA13053400130533093082132068
take
blood
Received command to
pressure
take
arm
bp
.
Press:Y.' and,ENTER on DELL/CSA
computet: . . . . ... . ..
.
.
.. .
..
.... .. .... .. ........ .. ..... . . .. .. ... ... . ... .. .. .. . .
. . . . : . : .........
. .. .
B 12:33.50
Ready to
BBA13053400130533093082132068
take
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
.....
blood
pressure
Visit 3 VERSION 3.0 01/95
61
P r e s s Y and ENTER on t h e 486 computerkevboard.The
IBM Computer Monitor..
4 8 6 ComputerMonitor
*M) PRELIMINARY
SCAN
NOW
486 s c r e e n w i l l now r e a d :
*
B 12 :33.50: BBAl3053400130533093082132068
..
.';,Readyt o t a k eb l o o dp r e s s u r e .
PRESS NEXT SITE WHEN DONE
.
.
.
..
. ..
. ' ..'
.
.
. .
.
arm. bp,
.
.Received 'coruiand'to
take
. ..
.
. .
.
.
.. . ..
B.'12 :.33;
5 0. .~.~ A 1 3 0 S 3 4 0 0 1 3 0 5 3 3 0 9 3 0 8 2 1 3 2 0 6 8
.
.
..: ...
8.2.24
.
..
,
.,
.. . .
. . .... ........ .....
... .
.
"'t.a.$e
.. ..
..
.
.
.. .
.
pressure
.
.
.
. .
.
.
Thesonographer now e n t e r s comments o n l o g s h e e t f o r r e f e r e n c e
l a t e r when computer comments w i l l b er e q u i r e d .
Please n o t e t h a t
t h e VCR w i l l c o n t i n u e i n RECORD mode.
8.3
L e f t Carotid Scan
8.3.1
Theheadandneck
are p o s i t i o n e d f o r t h e
exam o f t h e l e f t c a r o t i d .
foam r u b b e r wedge is p l a c e d o n t h e p a r t i c i p a n t ' s r i g h t s i d e a n d t h e
head i s r o t a t e d t o w a r d t h e
foam r u b b e r p i l l o w as o u t l i n e d i n t h e
i n t r o d u c t i o n of t h i s s e c t i o n .
8.3.2
"DO P r e l i m i n a r y S c a n
monitor.
8.3.3
A transversescanofthe
8.3.4
.
now, p r e s s n e x t
The
s i t e when done" message appears on
common c a r o t i d a r t e r y i s f i r s t p e r f o r m e d w i t h
the patient head'position andtransducerinterrogationangle
as shown
i n F i g u r e s 26-29. U s i n gf i n et r a n s d u c e ra n g u l a t i o n s
t o c l e a r l yd i s p l a y
is s l o w l y
the blood-intima boundaries within the vessel, the transducer
moved t o w a r d t h e m a n d i b l e u n t i l t h e w i d e n i n g o f t h e
carotid bulb, and
f i n a l l y t h e i n t e r n a l and e x t e r n a l c a r o t i d a r t e r i e s , are v i s u a l i z e d .
U s i n g t h e knowledgeof t h e r e l a t i v e o r i e n t a t i o n o f t h e i n t e r n a l a n d
which s h o u l d b e s t
e x t e r n a l c a r o t i d s from t h i s s c a n , t h e o p t i m a l a n g l e
d i s p l a y t h e t i p of t h e f l o w d i v i d e r m a y . b e d e t e r m i n e d u s i n g t h e
is
d i a g r a m s i n F i g u r e s 26-29. The e n t i r e l e n g t h of e a c h c a r o t i d s y s t e m
now s c a n n e d l o n g i t u d i n a l l y a t t h i s o p t i m a l i n t e r r o a a t i o n a n s l e
to
p r o v i d e an o v e r a l l q u a l i t a t i v e i m p r e s s i o n o f t h e e x t e n t
and s e v e r i t y of
disease and t h e q u a l i t y of t h e image a t t h i s i n t e r r o g a t i o n a n g l e .
U n u s u a la n a t o m i cf e a t u r e so rp o s s i b l el e s i o n s
a r e o b s e r v e d . Oral
comments are r e c o r d e d d u r i n g t h e e x p l o r a t o r y s c a n
t o assist t h e r e a d e r
during the reading process.
The c u r s o r i s p l a c e d i n t h e "Doppler" mode o n t h e B i o s o u n d i n s t r u m e n t
The s o n o g r a p h e rd e t e r m i n e sw h i c ha r t e r y
is t h e i n t e r n a l c a r o t i d
a r t e r y .T h e . c u r s o r
is f i r s t moved i n t o o n e b r a n c h a n d t h e n t h e o t h e r .
spectra on
The Doppler'key i s d e p r e s s e d i n o r d e r t o v i e w t h e D o p p l e r
i s d e p r e s s e da g a i n t o s t o p t h eD o p p l e r .
t h eB i o s o u n ds c r e e n .
Thekey
T h i s i s r e p e a t e di ne a c hb r a n c h .
The i n t e r n a l c a r o t i d a r t e r y
is
i d e n t i f i e d , based on t h e c r i t e r i a o u t l i n e d i n S e c t i o n 6.2.5.
panel.
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
- Visit
3 VERSION 3.0 01/95
62
8.3.5
Thesonographerverifies
that thecomputermonitorindicatesthe
COMMON OPTIMAL i s t o be s c a n n e d .
8.3.6
Theultrasoundtransducer
is moved p r o x i m a l l y t o v i e w t h e d i s t a l
c e n t i m e t e r o f t h e common c a r o t i d a r t e r y . T h e c u r s o r i s placed i n t h e
common
lumen ( S e c t i o n 6 . 3 . 2 ) .T h eb e s tp o s s i b l ei m a g eo ft h el e f t
carotid a r t e r y i n t h e o p t i m a l a n g l e
is obtained, as o u t l i n e d i n
S e c t i o n s6 . 1a n d6 . 2 . 3a n d
shown i n F i g u r e 1 9 .
8.3.7
T h es o n o g r a p h e r presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e
a t l e a s t f i v e cardiac c y c l e s , m a r k i n g t h e
s i t e o n v i d e o tape.
8.3.8
When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFTBIFURCATION,
he/she
presses NEXT S I T Ef o o t s w i t c h ,
o r , NEXT SITE on t h e s o n o g r a p h e r b o x
to
advancetheprogram
t o t h e n e x t site.
8.3.9
T h et r a n s d u c e r i s moved d i s t a l l y t o t h e b i f u r c a t i o n area. T h ec u r s o r
i s placed a t t h e t i p of t h e f l o w d i v i d e r( S e c t i o n6 . 3 . 3 ) .T h e
s o n o g r a p h e ro p t i m i z e st h e
a r t e r i a l i n t e r f a c e s a t t h i s s i t e a n da n g l e .
LEFT
for
8.3.10
T hceo m p u t emr o n i t oi nr d i c a t e s
LEFT
BIFURCATION.
T hs eo n o g r a p h e r
o p t i m i z e s t h e a r t e r i a l i n t e r f a c e s a t t h i s s i t e , a n d when t h e best
possible image i s o b t a i n e d , a s o u t l i n e d i n S e c t i o n s6 . 1a n d6 . 2 . 4 ,
presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e i m a g e f o r
a t least
five cardiaccycles,markingthe
s i t e o n v i d e o tape.
8.3.11
When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFT INTERNAL CAROTID,
h e / s h e presses NEXT S I T E footswitch, o r , NEXT S I T E o n t h e
s o n o g r a p h e rb o x t o a d v a n c e t h e p r o g r a m t o t h e n e x t s i t e .
8.3.12
T h es o n o g r a p h e r moves t h e t r a n s d u c e r d i s t a l l y
centimeter o f t h e i n t e r n a l c a r o t i d a r t e r y .
8.3.13
T h ec o m p u t e rm o n i t o ri n d i c a t e s
LEFT
INTERNAL
CAROTID.
T h ec u r s o r
i s placed i n t o t h e correct p o s i t i o n t o i n d i c a t e t h e t i p o f t h e
flow d i v i d e r a s d i s c u s s e di nS e c t i o n6 . 3 . 4 .T h es o n o g r a p h e r
o p t i m i z e s t h e f a r wall a r t e r i a l i n t e r f a c e s , and when t h e best
possible image i s o b t a i n e d , a s o u t l i n e d i n S e c t i o n s6 . 2 . 2
and
6.2.5, presses t h e SELECT f o o t s w i t c h a n d h o l d s t h e
image f o r a t
least f i v e c a r d i a c c y c l e s , m a r k i n g t h e
s i t e o n v i d e o tape.
8.3.14
When t h e s o n o g r a p h e r is r e a d y t o image t h e LEFT BIFURCATIONFAR
WALL, h e / s h e presses NEXT S I T E f o o t s w i t c h , o r , NEXT S I T E on t h e
s o n o g r a p h e rb o x t o a d v a n c e t h e p r o g r a m t o t h e n e x t s i t e .
8.3.15
Thecomputermonitorindicatesthe
LEFT BIFURCATION FAR WALL,
OPTIMAL ANGLE. T h et r a n s d u c e r i s moved b a c k t o t h e b i f u r c a t i o n
area t o o b t a i n a n i m a g e o f t h e b i f u r c a t i o n
a t theoptimalangle.
T h e c u r s o r i s placed a t t h e t i p of t h e f l o w d i v i d e r ( S e c t i o n
6 . 3 . 3 ) . .T h et r a n s d u c e r
i s s l o w l yt i l t e da l o n gt h e
arterial axis
so t h a t t h e f a r w a l l o f t h e b i f u r c a t i o n b e c o m e s v e r t i c a l i n t h e
c e n t e r o ft h ed i s p l a ys c r e e n .
T h es o n o g r a p h e ro p t i m i z e st h e
i n t i m a - m e d i ai n t e r f a c e so nt h ef a rw a l l .D u r i n gt h i sm a n e u v e r ,
t h e n e a r wall e c h o e s w i l l d e t e r i o r a t e . When t h e f a r w a l l
i n t e r f a c e e c h o e s are o p t i m i z e d ,a so u t l i n e di nS e c t i o n6 . 2 . 6 . 1 ,
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
-
t o theproximal
V i s i t 3 VERSION 3.0 0 1 / 9 5
63
thesonographerpressesthe
SELECT f o o t s w i t c h a n d h o l d s t h e
s i t e o nv i d e o
f o r a t least f i v e c a r d i a c c y c l e s , m a r k i n g t h e
image
tape.
When t h e s o n o g r a p h e r i s r e a d y t o image t h e LEFT BIFURCATION, NEAR
WALL, h e / s h e presses NEXT S I T E f o o t s w i t c h , or, NEXT S I T E on t h e
s o n o g r a p h e r box t o advance the program t o t h e n e x t s i t e .
8.3.16
-
Thecomputermonitorindicatesthe
LEFT BIFURCATION NEAR WALL.
OPTIMAL ANGLE.
The t r a n s d u c e r i s s l o w l y t i l t e d a l o n g t h e
arterial
axisbacktowardtheoptimalangleandthenbeyond,
so t h a t t h e
n e a r wall of t h e b i f u r c a t i o n becomes v e r t i c a l i n t h e c e n t e r of t h e
d i s p l a y screen. The c u r s o r is p l a c e d a t t h e t i p o f t h e f l o w
The s o n o g r a p h e ro p t i m i z e st h em e d i a d i v i d e r( S e c t i o n 6.3.3).
wall a s o u t l i n e d i n S e c t i o n
6.2.6.2.
intima interfaces on the near
D u r i n g t h i s maneuver, t h e f a r wall e c h o e s w i l l d e t e r i o r a t e . When
t h e near wall i n t e r f a c e e c h o e s are o p t i m i z e d , t h e SELECT
f o o t s w i t c h is p r e s s e d and t h e image is h e l d i n v i e w f o r
a t least
fiveconsecutivecardiaccycles,markingthe
s i t e on v i d e o t a p e .
T h es o n o g r a p h e rr e m o v e st h et r a n s d u c e rf r o mt h en e c k .
8.3.18
a t t h e PC t o see i f a s i t e w i l l be r e p e a t e d
o nt h el e f ts i d ef o rq u a l i t ya s s u r a n c ep u r p o s e s
(QC s i t e ) . I f no
QC s i t e s c a n i s r e q u i r e d o n t h e l e f t
side, t h e s o n o g r a p h e r presses
t h e NEXT S I T E f o o t s w i t c h .
8.3.19
If a QC s i t e s c a n i s r e w i r e d t, h em o n i t o rd i s p l a y s ,
i n red, t h e
QC s i t e a n dt h ef l o ws c r e e nh i g h l i g h t st h ec o d e .
The sonographer
o b t a i n s a n image of t h e QC s i t e and angle; moves t h e c u r s o r t o t h e
The sonographerlooks
appropriate landmarkandoptimizesthe
a r t e r i a l i n t e r f a c e s . When
t h e b e s t p o s s i b l e image h a s b e e n o b t a i n e d , h e / s h e p r e s s e s t h e
SELECT f o o t s w i t c h a n dh o l d st h ei m a g ef o r
a t l e a s t f i v e cardiac
cycles,markingthe
s i t e o nv i d e ot a p e .
The NEXT S I T E f o o t s w i t c h i s p r e s s e d twice t o a d v a n c et h ep r o g r a m
t o the optionscreenfordistensibility,
which w i l l a p p e a r a s
follows:
8.3.20
.
486 Computer Monitor
., ..
. . .
. ...
'
..
',
..:
IBM -Computer.Monitor
..
B 12: 33.50- BBAl30S3400130533093082132068
DISTENSIBILITY TRACKING
Ready t o . t a k e b l o o d . p ' r e s s u r e
TRACK LEFT SIDE
EXIT OR SKIP DISTENSIBILITY
Received.command'to take arm bp
'
B
12: 33.50, BBA13053400130533093082132068
Ready t o t a k e b l o o d p r e s s u r e
U s e t h e arrow key t o h i g h l i g h t EXIT OR SKIP i n y e l l o w , a n d p r e s s
.
ENTER
t o advancetheprogramandwipegelfromtheparticipant'sneck.
Themessagesonthecomputer
screen w i l l prompt t h e s o n o g r a p h e r t o
executesittingandstandingbloodpressures,
as d e s c r i b e d i n S e c t i o n
1.5.
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
- Visit
3 VERSION 3.0 01/95
64
8.3.21
Once the automatic blood pressure is finished, the participant is
thanked for their cooperation
and escorted from theroom.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
65
8.3.22
The sonographer presses Y and ENTER on t h e 4 8 6 keyboard.
The
s c r e e n w i l l now read:
486 ComputerMonitor
.
.
IBM ComputerMonitor
seconds
When you see t h e C:\
Ready t o t a k e . b l o o d p r e s s u r e
.
I Received command t o t a k e second . s t a n d i n g . b p
..
Press Y and ENTER on t h e D E u / C S A
..
'
w i l l t a k e n i n twenty
A secondstandingbp
Press E t o E x i t on IBM
on t h e IBM
486
..
.
.
. .
....
..
.
.
. .
.
.
.
.
..
.
.
..
"
.. ..
.. ..
.. .
.
.. .
.
'R' 12.33: 50 BBAi3053400130533093082132068
"
Press 'E' t o . e x i t . t h e . b pprogr&n!:.'.
.
.'
Press E on t h e IBM keyboard. The IBM bloodpressureprogram
is
.
a u t o m a t i c a l l ye x i t e d .
The program c r e a t e s a f i l ec o n t a i n i n gt h e
recordedbloodpressures,
which i s p l a c e d i n t h e s t u d y ' s d i r e c t o r y .
The f i l e i s named w i t h t h e p a r t i c i p a n t I D as t h e f i l e name andbp as
i t s e x t e n s i o n , i.e., X******.bp, where X r e p r e s e n t s t h e f i e l d center
code,andtheasterisksrepresenttheparticipant
I D number.
'
8.3.23
8.4
When t h e "Comments" s c r e e an p p e a r st,h seo n o g r a p h etry p ehs i s / h e r
comments f o r t h e l e f t s i d e images,and
p r e s s e s ENTER t o advance
t h e program.
Q u e s t iSocnr e e n s
The sonographeruses
Following "comments" i s a series of q u e s t i o ns c r e e n s .
t h e ARROW key t o s e l e c t t h e a p p r o p r i a t e a n s w e r , a n d
presses ENTER t o advance
t o the next screen.
8.5
Ultrasound
Conclusion
Upon completion of t h e f i n a l q u e s t i o n s c r e e n , t h e
p r o g r a ma u t o m a t i c a l l yc o p i e s
a l l t h e p a r t i c i p a n t f i l e s from t h e h a r d d r i v e t o t h e d i s k e t t e . The
s o n o g r a p h e ra p p l i e sl a b e l sa p p r o p r i a t e l y
and f i l l s o u t t h e log a h e e t (See
S e c t i o n 11).
-
5 1/4"
Copy t h eb l o o d pressure f i l e s o n t o a 5 114" f l o p p yd i s k e t t e .T h i s
f l o p paynt d
he
3 1/2" f l o p pcyo n t a i n i n g
t h e p a r t i c i p a nf ti l e s ,h o u l d
b e s e n t along w i t h t h e v i d e o t a p e t o t h e U l t r a s o u n d R e a d i n g C e n t e r .
I n a d d i t i o n , a 5 1/4" f l o p p y c o n t a i n i n g a backupcopyof
t h e b l o o dp r e s s u r e
f i l e s s h o u l d be stored a t t h e f i e l d c e n t e r .
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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RIGHT SIDE
EXTERNAL
5
X
cn
INTERNAL
TRANSVERSE
LONGITUDINAL
B-MODE IMAGE
3)
67
RIGHT SIDE
0-MODE IMAGE
TRANSVERSE
.
LONGITUDINAL
Figure 23.
Right Carotid Artery
-
Transverse Scan Investigation Procedure
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
68
TRANSVERSE
B=MBDE IMAGE
I
TRANSDUCE8 H U D 90'
LONGITUDINAL
Figure 24.
.
R i g h tC a r o t i dA r t e r y
-
T r a n s v e r s e Scan I n v e s t i g a t i o nP r o c e d u r e
ARIC PROTOCOL 6a. U l t r a s o u n d Scanning Procedures
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Visit 3 VERSION 3.0 01/95
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RIGHT SIDE
TRANSVERSE
B-MODE IMAGE
TRANSOUCER HWD 90°
~
LONGITWDtNAt
Figure 2 5 .
Right-CarotidArtery
- Transverse
Scan InvestigationProcedure
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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V i s i t 3 VERSION 3.0 01/95
70
LEFT SIDE
I
\
s
EXTERNAL
B=NIODE IMAG'E
TRANSVERSE
ROTATE
.
TRANSOUC€R HEAD 90°
LONQITUDIHAL
Figure 2 6 .
L e f t ,CarotidArtery
- TransverseScanInvestigationProcedure
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit
3 VERSION 3.0 01/95
71
LEFT SIDE
B-MODE 1MAGE
TRANSVERSE
LONGiTUDINAL
Figure 27.
Left Carotid Artery
- Transverse
Scan Investigation Procedure
72
LEFT S I D E
I
B-MODE IMAGE
LONQITUDINAL
Figure 2 8 .
Left Carotid Artery.
- Transverse Scan Investigation Procedure
AFtIC PROTOCOL 6a. U l t r a s o u n d S c a n n i n g P r o c e d u r e s
-
V i s i t 3 VERSION 3.0 01/95
. 73
LEFT S I D E
I
B=MODE IMAGE
TRANSVERSE
ROTATE
TRANSOUCEa HEAD
Figure 29.
Left Carotid Artery
- Transverse Scan
Investigation Procedure
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
74
9.
SONOGRAPHER TRAINING, CERTIFICATION
9.1
Training
AND MONITORING
The sonographer training program includes training sessions held
the at
respective field centers and the Ultrasound Reading Center,
followed,by
practice scans at the respective field centers and certification steps at the
field centers.
9.1.1
Stage 1
During the initial weeks, a new sonographer works with the certified
sonographers atthe field centerto observe the ultrasound area activities,
become familiar with the equipment, read the introductory material supplied
the URC, and become familiar with this scanning protocol.
9.1.2
Stage 2
The second phase (approximately
80 hours) at the Ultrasound Reading Center
consists of lectures, demonstrations, and practical laboratory experience
on
the following topics:
a.
b.
C.
d.
e.
f.
g*
h.
i.
j.
k.
1.
Overview of the Study.
Role of the Ultrasound Reading Center.
Ultrasonic PhysicsI, including basic physics concepts, units
of
measurement, and mathematics arising in the medical applications of
ultrasound.
Overview of atherosclerosis and a detailed discussionthe
of normal
artery wall.
Ultrasonic Physics2, including a discussion
of the properties of
ultrasonic waves, reflection at boundaries and scattering from small
objects.
Ultrasonic Physics 111, including
the Doppler effect, ultrasound
transducers and sound beams.
Pathology of Atherosclerosis.
Principles of Ultrasonic Instrumentation, including pulse-echo imaging
systems, pulsed Doppler systems, and spectral analysis.
Basic operationof the Biosound Phase2.
Instrument Performance Monitoring.
Basic Operation of the Custom Study Equipment
Principles of Ultrasound Arterial Scanning.
The remaining training time (at least
15 hours) at the field center will
be
spent practicing scanning technique
on volunteers with the protocol, including
the use of the study flow program and personal computer. The field center
coordinator andthe chief sonographer need
to help the novice sonographers
in
their recruitment and provide scheduled time for at one
least
volunteer
practice scan per day. The chief sonographer determines when
the new
sonographer has attained sufficient skills
to produce a scan according
to this
protocol. This portion of training is done under the direct supervision Of
the chief sonographer who guides, evaluates, offers suggestions for
improvements and answers questions
as they arise.
9.1.3
Stage 3
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit 3 VERSION 3.0 01/95
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75
When t h e c h i e f s o n o g r a p h e r d e t e r m i n e s t h e
new s o n o g r a p h e r i s r e a d y , t h e new
aonographerscansvolunteerswith
minimum s u p e r v i s i o n f r o m t h e chief
s o n o g r a p h e r . When t h ec h i e fs o n o g r a p h e r
has, reviewed 5 p r a c t i c e s c a n s t h a t
comply w i t h t h e s t a n d a r d s o f q u a l i t y o f i n t e r f a c e s , i m a g e a l i g n m e n t , c u r s o r
placement, i n t e r r o g a t i o n a n g l e s a n d o v e r a l l q u a l i t y o f s c a n n i n g , a n d t h e
new
a scan which conforms
to
sonogtapherhasdemonstratedthatshecanperform
protocol w i t h i n t h e time a l l o t t e d by h e r f i e l d center f o r a n u l t r a s o u n d scan,
thechiefsonographernotifiestheUltrasoundReadingCenterthatthe
sonographerhascompletedthe
p r a c t i c e phase.
9.1.4
Stage 4
Aftercompletionofthepracticephase,the
new s o n o g r a p h e r p e r f o r m s n o
more
t h a n t w o scans per d a yo na d u l tv o l u n t e e r s .
A t l e a s t t e n s c a n s are performed
i n t h i s mode. A l l s u c h s t u d i e s are i d e n t i f i e d a n d s e n t
t o t h e URC f o r
t a p e s . The scans s u b j e c t
e v a l u a t i o na l o n gw i t ht h en o r m a lw e e k l ys h i p m e n to f
t o t h i s e v a l u a t i o n are scans f o r w h i c h t h e u l t r a s o u n d e q u i p m e n t
is working
properlyandstudyparticipantshave
a r t e r i e s andanatomywhichpermit
the
walls t o be a d e q u a t e l yv i s u a l i z e d .T h e s es c a n s
w i l l be e v a l u a t e d by t h e lead
s t u d y sonographer ( o r h i s / h e r d e s i g n e e ) € o r e f f e c t i v e a d h e r e n c e t o p r o t o c o l .
Duringthisstage,feedbackonthisprocess
w i l l be given to the trainee.
t o thestudystandards,thesonographer
w i l l be
When t e n s c a n s h a v e c o n f o r m e d
c e r t i f i e d t o scan participants i n thisstudy,andhave.thedataresultingfrom
thosescansenteredintothestudydatabase.
9.2
9.2.1
Certification
C e r t i f i c a t i o n of Experienced Sonographers
A aonographerattainscertification
t o scanbaseduponherability,while
following t h e ARIC/FHS s c a n n i n g p r o t o c o l , t o v i s u a l i z e
a r t e r i a l walls
consistentwiththeprocessaverageof
a l l sonographers certified i n V i s i t s
one”and t w o of ARIC, as i n d i c a t e d by p a i r e d p o i n t s m a r k e d
by c e r t i f i e d readers
a t t h eU l t r a s o u n dR e a d i n gC e n t e r .
T h em o n t h l yr e v i e wo ft h es c a n ,b yt h el e a d
s o n o g r a p h e ra n dc h i e fs o n o g r a p h e r ,
m u s t , onaverage,
meet s c a n n i n gs t a n d a r d s .
A s l o n g as a s o n o g r a p h e r m a i n t a i n s v i s u a l i z a t i o n c o n s i s t e n t w i t h t h e p r o c e s s
a v e r a g e of h e r peers, a n d , t h e a v e r a g e o f m o n t h l y r e v i e w s c a n s
meet p r o t o c o l
s t a n d a r d s ,s h e
retains certificatio;.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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V i s i t 3 VERSION 3.0 01/95
76
9.2.2
Certification
ofNew Sonographers
When the novice sonographer has successfully met all training requirements,
as
9.1, written notification is sent
to him/her and to the
outlined in Section
chief sonographer at his/her field center, informing
the new sonographerof
his/her new status as a certified
sonographer.
9.2.3 Guest Sonographers
During the course of this Study
it is expected that, upon occasion, a
sonographer willbe unavailable to scan participants without being
able to
give sufficient prior notice
to allow for a reschedule
of the participant's
visit. If no provision were made for such
an eventuality, participant's would
be unduly inconvenienced, or may refuse to return
to undergo an ultrasound
evaluation. In such a case, in order
to prevent a loss of valuable data,
the
services of a guest sonographer
may be used. A guest sonographer isone who
is well-versed in the applied principles of carotid ultrasound, and
who is
familiar withthe ARIC/FHS ultrasound scanning protocol and study equipment.
The names and qualifications
of guest sonographers areto be registered with .
the Ultrasound Reading Center, where they will be ID
assigned
numbers.
Prior to substituting for a certified sonographer for this Study, the guest
sonographer isto re-read the protocol,
and review it with
the chief
sonographer or, in her absence, another ARIC/FHS certified sonographer. Tapes
containing scans recorded
by the guest sonographer are
to be clearly markedto
that effect. Likewise, a notation is
to be made on the log sheet.
Upon
receipt
of
these tapes at the Ultrasound Reading Center, these tapes
the tapes produced by certified sonographers. They will
first be reviewed by a certified reader. If the scans
are found to conform to
protocol, they will be logged in and treated from
on in
thenthe standard
fashion. If, however, the scans are
found not to conform to protocol, the
scans will not
be logged in and will not be read.
The field center
coordinator, chief sonographer
and guest sonographer will be informed
of the
areas wherethe scan did not conform
to the protocol.
will
not be logged in with
Due to the additional effort required
to process these scans, no guest
sonographer may scan for more than five days or fifteen scans within
two
a
month period without first obtaining speciai permission from the Executive
Committee of this Study. Should a field center require additional sonographer
support for an extended period, guest sonographers must undergo additional
training as specified
by the Ultrasound Reading Center
in orderto become
certified for this study.
9.2.4
Loss of Certification
When a sonographer's average monthly boundary visualization falls
significantly below the process average for one site, by a small amount for a
number of sites, if the visualization report reveals any trend towardloss
a
of visualization, or if the scans produced deviate from protocol,
theor,
average monthly scans reviewed do not meet protocol standards, she and her
chief sonographer will be notified of the specific nature and extent of loss
of consistency so that remedial steps can be taken
to improve visualization in
those sites.
9.2.5
'
Scanning Process Control
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 01/95
77
The methods employed
by the Ultrasound Reading Center for assuring
the quality
of ultrasound data are based
on the work of
F. Edwards Demming,J.M. Juran and
Ellis Ott. Tools include process capability and statistical process control
charting techniques, with consistent performance and constant improvement
as
goals.
Timely feedback is critical
to the successof this procedure. Therefore, on a
routine basis, basedon frequency of scanning and sonographer consistency,
sonographers will be given detailed reports of their performance,
be
and
notified of the extent to which they conform
to the quality and quantity
of
data gathering exhibited by
the Study sonographers as a group. Below are
indicated the steps to be followed basedon each sonographer's conformanceto
these standards.
9.2.6
Conforming
a
0
a
9.2..7
Non-conforming
a
a
a
a
.. ,
a
a
9.2.8
The sonographer, chief sonographer and study coordinator will
receive written notification of her scanning performance.
The sonographer will continue to scan.
The URC will continueto monitor levels of visualization.
a
a
slight
The sonographer, chief sonographer and study coordinator will
receive written notification of her scanning performance.
The chief sonographer will check equipment performance and
preventive maintenance record.
The sonographer will review the scanning protocol the
with
chief
sonographer.
The chief sonographer will observe
the sonographer perform that
part of the scan which was found
to conform
not
to standards.
The sonographer will discuss with the chief sonographer
to ways
improve visualization at the specific
site(s).
The sonographer will report back
to the URCon the steps taken
to
effect the improvement.
The sonographer will continue
to scan.
The URC will continue
to monitor levels of visualization.
Non-conforming
a
-
- moderate
The sonographer, chief aonographer and study coordinator will
receive written notification the
of sonographer's scanning
performance.
The chief sonographer will check equipment performance and
preventive maintenance record.
The sonographer will review the scanning protocol with
the chief
sonographer.
The sonographer will review training materials on the principles
of physics and anatomy.
The chief sonographer will observe the sonographer perform that
part ofthe scan which was
found notto conform to Standards.
The lead study sonographer will identify patterns which might
reveal the reason for failing
to conform to the standard, document
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
78
0
0
0
9.2.9
areas in needof improvement, and communicate her findings
to the
sonographer.
The sonographer and chief sonographer will discuss waysto improve
visualization at the specific sites.
The sonographer will practice that part ofthe scan on volunteers.
The sonographer will report backto URC on steps takento effect
improvement.
The sonographer will continue to scan.
The URC will continue to monitor levels of visualization.
Non-conforming'- severe
The sonographer, chief sonographer
and study coordinator will
receive written notification
of the sonographer's scanning
perform'ance.
The sonographer willstop scanning cohort participants
immediately.
The chief sonographer will check equipment performance and
preventive maintenance record.
The lead study sonographer will identify patterns which might
reveal the reason €or failing
to conform to the standard, document
areas in needof improvement, and communicate her findings
to the
sonographer.
The sonographer will review training materials
on the principles
of physicsand anatomy.
The sonographer will review the scan protocol the
with chief
sonographer.
The chief sonographer will observe the sonographer as he/she
performs that part of the scan which was found
to conform
not
to
standards.
The sonographer andthe chief sonographer will discuss ways
to
improve visualization at those specific sites.
The sonographer will produce a taped scan of a volunteer of cohort
age. The sonographer will then make practice scans
on volunteers.
When the chief sonographer determines that sufficient improvement
has been made, the sonographer will make another taped scan of the
same initial volunteer. Both tapes will be sent
to the UC for
evaluation.
The sonographer will report back
to URC on steps she has taken
to
effect improvement.
When the URC determines that improvement has been demonstrated,
with visualization ator above the study average for all sites,
the sonographer, chief sonographer and field center coordinator
will be notified,and the sonographer may then resume scanning.
The URC will continueto monitor levels of visualization.
- Visit 3 VERSION 3.0 01/95
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
9.3
Monitoring
Sonographer performance is monitored throughout
the Atherosclerosis Risk in
Communities Study at the respective field centerstheandUltrasound Reading
Center.
9.3.1
Monitoring at Field Center
Each monththe chief sonographer reviews
on0 scan per sonographer for hie/her
field center. The primary purpose for review is
to ensure the quality of the
study data and adherenceto the scanning protocol. The B-mode images are
evaluated for overall image quality, the presence and clarity
of the arterial
wall boundaries,and the presence of anatomical landmarks and a cursor
indicating the location of an anatomical landmark the
and vessellumen.
The timeof the month for sonographer review for each sonographer is
determined by the chief sonographer, but is not
the same from month
to month.
All reviews are sent
to the URC before and no later the
thanend ofthe third
week of that month. It is recommended by the Ultrasound Reading Center that
only one review per week be performed to reduce
the time commitment during any
one week. The chief sonographer keeps a log the
of review and discusses her
findings withthe sonographer on a timely basis.
9.3.2
Monitoring at the Ultrasound Reading Center
Sonographer performance is monitored at the Ultrasound Reading Center using a
number of quality assurance procedures. The quality assurance procedures
include but are not limited to:(1) comparing results of repeat studieson a
randomly selected identical site and angle of individual participants;
(2)
periodic reports containing statistics of boundary visualization by individual
sonographer and study wide;
(3) visual review of randomly selected participant
scans; ( 4 ) on-site monitoring of sonographer performance by designated URC
.personnel. Reports are'generated and distributed by
the Ultrasound Reading
Center.
In addition,the Ultrasound Reading Center can review
the same participant
studies reviewed bythe chief sonographers at the field centers.The
sonographer evaluation form is completed atURC,
theand the results are
compared to the chief sonographer's form. Any significant differences between
the chief
evaluations, or any significant problems are discussed with
sonographers to resolve thedifferences. Results of these sonographer
evaluations are used
to help maintain high standards for participant studies
and are part of an ongoing sonographer recertification process.
The Ultrasound Reading Center readers read the ultrasound images from all the
data collection procedures
and the quality assurance images. Image
interpretation results from study images and quality assurance images from the
same site and angle are compared for use in sonographer quality assurance
procedures. The purpose of this evaluation procedure is
to determine the,
%consistencyand reproducibilityof scanning and of interpreting ultrasound
images. The results of these evaluations are reported periodically
to the
ARIC Coordinating Center and the field centers.
ARIC PROTOCOL 6a.
-
Ultrasound Scanning ProceduresVisit 3 VERSION 3.0 0 1 / 9 5
80
9.4
The E-Mode Study Scan Evaluation
Form
The current versionof the B-mode study scan evaluation formis on file at the
Ultrasound Reading Center in Winston-Salem, NC. This form provides a forum
f o r a detailed accounting of the conformance to scanning protocol as described
in this document.
9.5
The Lead Study Sonographer
The Ultrasound Reading Center
is responsible €orpre-certification,
certification and re-certification ofsonographers. Certifying processes
involve the review and evaluation B-mode
of
scans, as well as statistical
evaluation of sonographer performance. The lead study sonographer provides
feedback to the sonographer, his/her chief sonographer toandthe Ultrasound
Coordinator. This feedback to the sonographerincludes, but is not limited
to, site visits, verbal communication over the phone or in form
the of taped
comments of reviewed scans, written communication, in the form of formal
reviews of scans, statistical evaluations of performance and recertification
reports.
.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
81
10.
SUMMARY OF CHIEF SONWRAPHER DUTIES
The c h i e f s o n o g r a p h e r s ' d u t i e s
are a v i t a l p a r t o f m a i n t a i n i n g t h e q u a l i t y o f
t h eu l t r a s o u n dd a t a
a t t h e f i e l d c e n t e r s . The e s t i m a t e d t i m e - e f f o r t
required,
e x c l u s i v e of t r a i n i n g new sonographers, is 10 p e r c e n t .
A summary o fd u t i e s
is
l i s t e d below.
a.
A s a i s t st h eU l t r a s o u n dR e a d i n gC e n t e ri nt r a i n i n g
a s d e s c r i b e d i n S e c t i o n 9.1.3, S t a g e 3 .
b.
Responsible f orre v i e w i n gs o n o g r a p h esr c a n n i n gp e r f o r m a n c e
i n S e c t i o n 9.3.1.
C.
Responsible f o r e v i e w i n gt h eq u a l i t ya s s u r a n c ed a t ap r e p a r e db yt h e
U l t r a s o u n dR e a d i n gC e n t e rf o r
t h e field center,andforeach
are
s o n o g r a p h e r a t t h a t f i e l d center. C u r r e n tv a l u e sa n dt r e n d s
reviewed,and
if problems arise, t h e c h i e f s o n o g r a p h e r a n d t h e
Ultrasound Reading C e n t e r w i l l work t o g e t h e r w i t h t h e s o n o g r a p h e r
i m p l e m e n ts o l u t i o n s .
new s o n o g r a p h e r s
to
to
d.
R e s p o n s i b l ef o r e p o r t i n gu l t r a s o u n d
the Ultrasound Reading Center.
e.
R e s p o n s i b l ef o sr c h e d u l i n gp r e v e n t i v em a i n t e n a n c ev i s i t as n do t h e r
s e r v i c e c a l l s a s needed.Beforeeach
v i s i t or c a l l t o Biosound, a l i s t
of problems a r e w r i t t e n and given t o them, i n case s p e c i a l t e s t
equipmentorboards
are required.
fR
. e s p o n s i b l ef ocr o m m u n i c a t i o n
g *R e s p o n s i b l e
area equipment
problems
as d e s c r i b e d
with the
U l t r a s o u n dR e a d i n g
for s o n o g r a p h er e c e r t i f i c a t i o n
ARIC PROTOCOL 6a. UltrasoundScanningProcedures
Center.
as o u t l i n e di nS e c t i o n
- Visit
9.
3 VERSION 3.0 0 1 / 9 5
82
11.
LABELING AND MAILING TO THE ULTRASOUND READING CENTER
11.1
Labeling of Video Cassettes and Diskettes
Video cassette and diskette labels identify the field center and are numbered
sequentially. The starting number for each field center is listed below:
Forsyth ARIC/FHS:
Jackson ARIC:
Minneapolis ARIC/FHS:
Framingham FHS:
Salt Lake City FHS:
Hagerstown ARIC:
FlOOOlX
F20001X
J30001X
M50001X
B60001X
U80001X
W70001X
The final character, shown as an "X" here, is a code check character. Each
field center maintains a log that records the video cassette number and the
participant identification numbers on that cassette (Log sheet reference
Appendix 5). The information in columns 1-10 must be included and filled out
by sonographers before theysend it to the Ultrasound Reading Center.
--
11.1.1
Each video cassette is labeled with the video cassette number and
no more than four participant identification numbers. Note that
the video cassette number appears only once on the short edge
the video cassette. The video cassette box is also labeled on the
short edge. (See labeling diagram
Appendix 6)
-
11.1.2
Each diskette is labeled with the diskette number (which is
identical to the video cassette number)
and the participant
identification numbers. The diskette is placed with its matching
video cassette for shipping. (See labeling diagram
Appendix 6)
-
11.2
Content of Mailing
Each weekly mailing from the field centers to
contains:
a.
the
Ultrasound
Reading
Center
e.
f.
g-
Video cassettes for the participant ultrasound studies completed the
previous week.
Diskettes containing the participant files for the ultrasound studies
completed the previousweek.
Diskettes containing the blood pressure files for the ultrasound
studies completed the previous
week.
A copy of the week's log sheet. (See Appendix 5)
A copy of the Shipping Log sheet for the week.
A video cassette containing phantom scan(s), if appropriate.
Biosound Service Report, if appropriate.
11.3
Frequency o f - Mailing
b.
C.
C.
The video cassettes, diskettes and lists described in Section 11.1 are mailed
t o the Ultrasound ReadingCenter.
each weekno later than Tuesday afternoon
The Ultrasound Reading Center needsto receive these cassettes no later than
Wednesday afternoon.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures Visit 3 VERSION 3.0 01/95
of
11.4
PackageLabeling
The address labelfrom each field centerhas the following information:
a.
b.
C.
d.
Field center personnel sending the
package.
Fieldcenterreturn
address.
The shipping number from the Shipping Log sheet.
Address label to the Ultrasound Reading Center:
Ultrasound Reading Center
4310 Enterprise Drive, Suite C
Winston-Salem, North Carolina 27106
Mailing is by services guaranteeing package arrival
at the Ultrasound Reading
Center no later than
mid-afternoon on the Wednesday following the
mailing.
11.5
Verification of Mailing Contents
The contents areverified upon receipt of shipment at URC.
discrepancies, the field center w i l l be notified.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
If there are any
Visit 3 VERSION 3.0 01/95
a4
12.
POLICIES/PROCEDURES FOR REPORTING B-MODE ULTRASOUND RESULTS
12.1
RoutineReporting
12.1.1
Routine Report by Field Center
to Participant
A clinic visit report is issued by the field center, informing the participant
that an evaluation will be made
of the ultrasound examination and that further
notification will be made ONLY in the case
of unusual findings. A sample
letter appearsbelow.
“Portions of the carotid arteries (blood vessels in the neck) measured.
were
We will contact you (and your physician)
if the opening of an artery is
narrowed t o 2 millimeters or less.
12.1.2
Routine Report from Ultrasound Reading Center
t o Field Center
The ultrasound reportt o each field centeris a weekly listof participant
studies read the previous week andalert
an designation whenever an alert
condition was detectedat the Ultrasound ReadingCenter. The list will
consist of the followinginformation:
a.
b.
C.
d.
e.
f..
Participant
Identification
numbers
Participant last name, first and middle initial
Dateofbirth
Raceandgender
Examination
date
Alert (Yes or Blank)
12.2 . Procedures for Non-routine Results
12.2.1
If lumen narrowing t o 2 mm or less is detected by the sonographer:
The sonographer identifiesa study
the log sheet. The URC identifies
the URC ultrasound clinician. Such
prior to the routine reading
by URC
12.2.2
as a possible alert and notes the reason
thestudy for review and confirmationby
reviews take placeon a regular basis,
readers.
on
If lumen narrowing t o 2 mm or less is detected by the reader:
The study will proceed through the routine reading
process.
The reader
identifies a study as a possible alert. The study is reviewed by the URC
a regular basis.
ultrasound clinician. Such reviews take place on
12.3.1
Report from Ultrasound Reading
Center t o Field Center
A report is sent by the URC to the
field center listing all studies for which
possible alerts were citedby the sonographer. This report will indicate
which studies were and were
not confirmed as alerts.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
Visit 3 VERSION 3.0 01/95
85
12.3.2
Reporting of
Confirmed
Field Center
Alerts by t h e U l t r a s o u n d
R e a d i n gC e n t e r
to
URC c l i n i c i a n t o t h e f i e l d c e n t e r w i t h
a brief
e v a l u a t i o n .T h ef i e l dc e n t e rt h e nc o n t a c t st h ep a r t i c i p a n ta n dt h e
care. The URC s e n d s a report summarizing
p a r t i c i p a n t ' sp r o v i d e ro fm e d i c a l
a n a b n o r m a l i t y was i d e n t i f i e d a n d ,
thefindingsoftheclinician,whether
a clinicalevaluation.
w h e r ea p p r o p r i a t e ,t os u g g e s t
A report i s s e n t b y t h e
12.3.3
R e p o r t i n goC
f onfirmed
Participant
Alerts by t h eF i e l dC e n t e r
to the
An examples o f a l e t t e r t o send t o t h e p a r t i c i p a n t s i n whom a c a r o t i d
u l t r a s o u n d a l e r t v a l u e is confirmedappearbelow.
Alert for lumennarrowing
t o 2 mrn o r less:
"As a p a r t i c i p a n t i n t h e
ARIC Study,youhad
a B-mode. u l t r a s o u n d e x a m i n a t i o n
c a r o t i d a r t e r i e s ( b l o o dv e s s e l si ny o u rn e c k ) .D u r i n gt h a t
was f o u n d i n t h e
e x a m i n a t i o n ,n a r r o w i n g of t h e o f t h e v e s s e l
a r t e r y ( s ) .S u c hn a r r o w i n g
i s m o s to f t e na s s o c i a t e dw i t ha t h e r o s c l e r o s i s
( h a r d e n i n g of t h e a r t e r i e s ) . While some narrowing i s found i n many p e o p l e ,
t h e amount o f n a r r o w i n g i d e n t i f i e d
onyourstudy
was g r e a t e r t h a n e x p e c t e d
( r e s i d u a l lumenof
2 mm o r l e s s ) . W
e recommend t h a t you c o n s u l t w i t h your
physician t o determinewhetherfurtherevaluation
or t r e a t m e n t i s n e c e s s a r y .
If you do n o t have a p e r s o n a l p h y s i c i a n t h e ARIC o f f i c e w i l l be happy t o work
w i t hy o u t o a r r a n g e f o r a r e f e r r a l . "
t o m e a s u r et h e
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
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V i s i t 3 VERSION 3.0 01/95
86
13
See
PARTICIPANT SAFETY PRECAUTIONS
Manual 2.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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V i s i t 3 VERSION 3.0 01/95
A -
APPENDIX I:
1
DOPPLER SIGNAL IDENTIFICATION OF THE INTERNAL CAROTID ARTERY
It is important t o carefully distinguish between the internal and external
c a r o t i d arteries u s i n g two c r i t e r i a . F i r s t , t h e i n t e r n a l n o r m a l l y h a s
a
s i g n i f i c a n t l yl a r g e rd i a m e t e rt h a nt h ee x t e r n a l ;s e c o n d ,t h eb l o o df l o w
is
v e l o c i t y p a t t e r n i n t h e two v e s s e l s as d e t e r m i n e d w i t h D o p p l e r u l t r a s o u n d
d i s t i n c t l yd i f f e r e n t .
Used t o g e t h e r ,t h e s e two c o n s i d e r a t i o n s permit t h e
i n t e r n a l c a r o t i d a r t e r y t o be i d e n t i f i e d w i t h a h i g h d e g r e e o f c o n f i d e n c e .
Althoughtributariesoriginatingfromtheexternalcarotidartery
may
occasionallybeviewedwith
B-mode u l t r a s o u n d t o h e l p i n t h i s d i f f e r e n t i a t i o n ,
D o p p l e ru l t r a s o u n di nm o s tc a s e s
i s more e f f i c i e n t a n d s p e c i f i c f o r t h i s
separation. Themethod and c r i t e r i a f o r t h i s i d e n t i f i c a t i o n are a s f o l l o w s :
A B-mode image i s o b t a i n e d of t h e c a r o t i d b i f u r c a t i o n w h e r e t h e
common c a r o t i d
a r t e r yd i v i d e s .
I n some instances, t h eb e s ta n a t o m i c a la n g l e
w i l l show t h e
arteries.
f l o w d i v i d e r a s well as t h e p r o x i m a l i n t e r n a l a n d e x t e r n a l c a r o t i d
I n t h e r e m a i n i n g cases, t h e f l o w d i v i d e r a n d o n l y o n e v e s s e l c a n b e s e e n f r o m
a s i n g l ea n g l e .I nt h o s ei n s t a n c e s ,t h eo t h e ra r t e r yc a n
be v i s u a l i z e d b y
gentlyrockingtheultrasoundtransducerbackandforth
i n angle or position
or both.Doppler
is u s e d t o d i f f e r e n t i a t e i n t e r n a l a n d e x t e r n a l c a r o t i d
arteries i n t h e s e i n s t a n c e s .
To o b t a i n a Doppler sample o f each a r t e r y , p r e s s t h e DOP CUR b u t t o n o n t h e
instrumentpanelandusing
the tracking ball on the instrument panel
move t h e
Doppler c u r s o r so t h a t it i s p o s i t i o n e d w i t h i n t h e lumen o f t h e b r a n c h
f a r t h e s tf r o mt h es k i n
surface. The DOP b u t t o n i s p r e s s e d . Thesonographer
t o t h e Doppler s i g n a l by
observes the tracing on the left monitor and listens
t u r n i n gu pt h ea u d i oo nt h ei n s t r u m e n tp a n e l .I ft h eu l t r a s o u n dt r a n s d u c e r
is
i n t h e i n t e r n a l carotid a r t e r y , t h e f l o w p a t t e r n
w i l l be t h a t o f a l o w r e s i s t a n c eb e d .T h i ss i g n a lh a s
a r a p i du p s t r o k e and a q u a s i - s t e a d yf l o w
The f l o wc o n t i n u e st h r o u g h o u tt h e
cardiac c y c l e
t h r o u g hs y s t o l ea n dd i a s t o l e .
and b e g i n s t o i n c r e a s e a g a i n a t t h e n e x t s y s t o l e .
away from t h e h e a r t t h r o u g h o u t t h e c y c l e
is
Flow directed t o w a r d t h e h e a d a n d
r e p r e s e n t e d a s a t r a c i n ga b o v e t h e b a s e l i n ei nF i g u r e
15.
I ft h eD o p p l e r
s i g n a l d o e s not correspond t o theexpectedpattern,
t h e cursor is placed
of t h e common c a r o t i d a r t e r y .
The e x t e r n a l c a r o t i d
w i t h i nt h eo t h e rb r a n c h
a r t e r y is u s u a l l y n e a r e r t h e s k i n s u r f a c e
when viewedfrom a n a n t e r i o r a n g l e
and i s a h i g h - r e s i s t a n c ev e s s e l .
The c h a r a c t e r i s t i c s of D o p p l e rs i g n a l i n
t h i s v e s s e l are a f o r w a r d f l o w w i t h
a s h a r pu p s t r o k ea n ds o m e t i m e s
a highr e s i s t a n c e a r t e r y is cessationofflowbeforetheonsetofthenextsystole
as
d e f i n e di nF i g u r e
16. A D o p p l e rs i g n a lf o r
a c o m b i n a t i o no fi n t e r n a la n d
e x t e r n a l carotid f l o wp a t t e r n s is i l l u s t r a t e d i n Figure 17.
T h e e x t e n t t o whichtheDoppler
e f f e c t "occurs" depends upon
the relative
t h e direction of propagation of
orientation of the direction of blood flow and
are p a r a l l e l , t h e e f f e c t
is
t h eu l t r a s o u n dp u l s e .I ft h et w od i r e c t i o n s
maximum. I f t h e d i r e c t i o n s
are p e r p e n d i c u l a r ,i np r i n c i p l e
NO DOPPLER
EFFECT
WILL OCCUR.
While it i s i m p o s s i b l e g e t t h e d i r e c t i o n s o f u l t r a s o u n d p r o p a g a t i o n
and b l o o d
a s c l o s e t o p a r a l l e l a s possible i n
f l o w e x a c t l y p a r a l l e l , t h e ys h o u l db e
o r d e r t o o b t a i n a s t r o n gD o p p l e rs i g n a l .R e g a r d l e s so fw h e t h e rt h e
a i d e l o o k i n g or i n l i n e D o p p l e r f u n c t i o n s are u s e d , t h e two d i r e c t i o n s m u s t NOT
BE PERPENDICULAR.
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
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V i s i t 3 VERSION 3.0 01/95
A - 2
APPENDIX 11:
SOFTWARE TROUBLESHOOTING
Common Problems
and
Their
Solutions
Listed below are some problems
you could encounter, and some suggestions on
how t o correct them.
At the C:> prompt, type
aricscan and press
the ENTER key.
The message badcommand or file name indicates
entered. Correct the spellingand try again.
that
an
incorrect
command
was
C: >Date
If the correct date appears, press the ENTER key. If the date
die-played is' incorrect, type in thecorrect date using the exact format
displayed on the computer screen. Example: 01-14-93
C :>Time
If the correct timeappears, press the ENTERkey. If the displayed
time is incorrect, type in the time of
day using the exactformat
displayed on the computer screen. Example: 10:30
Demographic screen entries:
PartiCiDant ID:
Six digits must be entered. If a digit is left off, it must
be entered t o continue or backspacet o correct entire ID.
Visit:
Two digits must be entered. Example: 07 referring t o Visit
03. If one digit is entered, the computer waits for the
second digit.
SonoqrarJher:
Three digits must beentered. If two or less digits are
entered, you will not be able t o continue. If by accident a
fourth digit is pressed, an ERROR screen appears. Press the
ENTER key. The demographic screen reappears. Corrections can
be made at this time by using the backspacekey.
Cassette:
The identification of the tape will automatically appear on the
demographics screen. (the tapehas to be put in before this
screen) Verify tape in VCR and screen ID'S match.
Initials:
Enter the participant's first and middle initials. If the
participant has no middleinitial, enter the one initial and
press ENTER. To insert a period for no initial press ENTER
again. Once the period appears press ENTER againto move to
the next field. If it is necessary to makea correction, use
the left arrow key to return to the INITIALS column to make
corrections.
Last Name:
Type.only thefirst five digits of the
participant's last name
and press the ENTERkey. No more than five digits will be
recorded on file.
Gender:
Enter F or M. If a different letter is entered, an ERROR
message appears. Press the ENTERkey and type in the correct
entry.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures- Visit 3 VERSION 3.0 01/95
A - 3
Enter 8 , W or 0. If something different is entered, an ERROR
message appears. Press the ENTER key and type in the correct
entry.
Race :
Date Of Birth:
Type in the participant's date of birth. If a nonexistent
number of a month or day is entered, for example: 14/12/32,
or 12/32/32, an ERROR message appears. Press the ENTER key
and type in the correct date of.birth.
Note: If an incorrect date of birth that
a valid date is
entered, the sonoarauher is resDonsible for correctingit at
the verification screen.
Note:
The backspacekey can
is pressed.
be used to make corrections until the ENTER
key
Note:
If you are at the end of the demographics screenand notice an
incorrect entry, use the left arrow key to toggle back to make
necessary corrections.
Common Problems Associated With
the
the Scanning Screen:
If the NEXT SITE footswitch is pressed instead of the SELECT footswitch for
a
particular site, the program will toggle forward. You can immediately correct
for this by pressing the PREVIOUS SITE on
sonographer's
the
box t o toggle back
to the skipped
site, and then tone theimage using the SELECTfoot switch.
Accidently pressing the SELECT
instead of NEXT SITE before pressing RECORD
on
the sonographer's box will cause thecomputer monitor to blink for
5 seconds.
The study flow screen will return after the blinking stops. The screen will
read "Press RECORD" on the
sonographer's box. A WAIT message appears while
the VCR isautomatically put into recordby the computer.
Software appears tobe "Hung":
-
the scan can be
When the software will not respond t o the input commands
continued by following these steps:
1.
fast forward thetapetothe
end of recordedspace
2. press RECORD on the VCR key pad
3. verbally identify the SELECT and NEXT SITE segments on the tape
4. Note on loasheet for this tape to be re-striped.
5. Record answers to questions that would normally be on the US
screens:
Lesion
Sonographer impression
Distensibility Code
Deviations in Protocol (i.e. B-mode, BP and Distensibility)
Wait Screens: If the wait screen seems hung, it has a time out feature
after 2 minutes the software will issue the command t o retry the
procedure.
A
-
"Rewind for 8 seconds and ENTER" message appears when the VCR
and computer
have. lost the addressand does not know what sectionof the tape it is
at. Sometimes this step willhave to be repeated more than
once. Be
hRIC PROTOCOL 6a. Ultrasound Scanning Procedures
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3 VERSION 3.0 01/95
A - 4
sure the rewind8 seconds starts with recorded space on thetape.
counter will count backwards
when rewinding in a recorded space.
Pause
&
Record
mode
The
onVCR:
If VCR is in the PAUSE& RECORD mode and does not release toRECORD
only, press the PAUSEkey on theVCR key pad to releaseit manually.
The program will then proceed
through the flow of the scanning
program.
The VCR will then go into
RECORD and you can continue with the
scan.
Comment Screen l a m e a r s huna):
If the screenis blank with no"COMMENTS" heading, the sonographer
should enter the comments
and press ENTER to continue through the
program.
To Check
HeaderFile:
To change directory to ARIC
at the c : > type cd(space)ARIC <ENTER>
At C:\ARIC> type(space)header and 2 four digit f ' s will be displayed.
The first four digits are the tape
number and should match the tape
being used; or, if a new tape is to be used the # should be one less
than the new tape
number.
If the t a w number matches the tape beins
used no edit is needed. At
the C:\ARIC> type cd(space)\ <ENTER> to return to the root
directory.
Begin new scan.
.
..
If the tape number
does not match the tape beins used do the
following:
At the,C:\ARIC> type edit(space)header <ENTER>. A menu dr.iven program
will display thefile. Use the arrow keys to move the cursor to the
tape number. Insert the correct number and .delete the old numberby
using the deletekey.
-
When chanses are completed press Alt(key)+ F(key) t o get the file
menu. Press X t o exit. A gray menu box will appear and ask if the
changes are t o b e saved. Press Y and <ENTER>. This will return you to
the C:\ARIC>.
Type cd(space)\ <ENTER>. Begin new scan.
Select liaht is on at the besinnins of a scan:
If the Select light
is on at the beginning of a scan, it must be reset
before that scan can be
performed. To reset the select lisht
At the
C : \ > type cd(space)test <ENTER>.
At C:\TEST> type initff <ENTER>.
This will cause the selectlight to go off. Then, at C:\TEST> type
cd(space)\<ENTER> to return to the
root directory of the computer.
-
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
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Visit 3 VERSION 3.0 01/95
A -
APPENDIX 111:
5
TROUBLESHOOTING
Phase 2 Setup
The i n s t r u c t i o n s o n t h e P h a s e
2 rightmonitorsuggeststhatanykeycan
be
pressed t o d i s p l a yt h em a i n
menu. However, i f t h e l e t t e r "D" is n o t pressed
a t tfiat p o i n t , t h e P h a s e
2 c a n n o t be placed i n debug mode w i t h o u t f i r s t
i s n e c e s s a r y ,f o l l o w
s h u t t i n g down a l l of t h ee q u i p m e n t .I fs h u t d o w n
instructions in Section 6 t o startuptheequipment.
I f t h e PROBE 2 key i s p r e s s e d , a No Probemessage
key t o c o n t i n u e .
appears.
Press t h e PROBE 1
If a wrong menu key i s p r e s s e d , press t h e ESCAPE k e y , l o c a t e d o n t h e P h a s e
keyboard, t o r e t u r n t o t h e p r e v i o u s menu.
A t any time d u r i n g t h e s e t u p ,
I.D. is i n c o r r e c t , p r e s s t h e
2
it i s d i s c o v e r e d t h a t t h e p a r t i c i p a n t ' s
name o r
menu s c r e e n r e t u r n s .
Press t h e 4 t h menu key t o d i s p l a y S e t u p . Press t h e f i r s t menu k e y f o r P a t i e n t
menu. Press t h e f i r s t o r second menu key t o c o r r e c t t h e p a t i e n t i n f o r m a t i o n .
menu, t h e CLEAR k e y ,l o c a t e d
on t h e
Once i n t h e N a m e o r P a r t i c i p a n t I . D .
Phase 2 keyboard,can b e u s e d t o clear a n i n c o r r e c t e n t r y .
ESCAPE k e y u n t i l t h e m a i n
Remember t h a t t h e DOP CURSOR key i s u s e d as a t o g g l e .
t h e c u r s o r a t a n y g i v e n time.
I t canremove
or r e t u r n
-
If the Dopplerdoesn't work well c h e c k c u r s o r a l i g n m e n t
w i t h blood flow (see
Appendix I ) and t h e f o c u ss e t t i n g . .
I t s h o u l d be a l i g n e d t o t h e c u r s o r
a r t e r y .C h e c kf o rB u b b l e si nt r a n s d u c e r .F o c u sa n d
b u b b l e s i nt h et r a n s d u c e r
sreatlv a f f e c t b o t h D o p p l e r a n d D i s t e n s i b i l i t y .
-
TO ensure that the image orientation
i s in "standard" mode, t h e
f o l l o w i n g s h o u l d be completed d a i l y :
Select Imaae C o n t r o l m t i o n s
Select
Select S t a n d a r d
Press ESCAPE t o e x i t o u t t o Main Menu
Intheeventthattheequipment
s t i l l f a i l s t o o p e r a t e as d e s i g n e d , c a l l
theBiosoundtechnicianforassistance.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
- Visit
3 VERSION 3.0 0 1 / 9 5
A - 6
APPENDIX IVr
BIOSOUND KEYBOARD
ARIC PROTOCOL 6a. Ultrasound S c a n n i n g Procedures
- Visit
3 VERSION 3.0 01/95
A - 7
APPENDIX Vr
+A
LOG SHEET REFERENCE
For field
center u s e t o r e c o r d e v a l u a t i o n r e c o r d / n o t i c e e f r o m
t h e URC
+B
P l a c e cassette I D l a b e l h e r e
+C
P a r t i c i p a n t ID#
4D
Participant date of birth
+E
P a r t i c i p a n t ' s l a s t name, f i r s t i n i t i a l , t h e n m i d d l e
+F
Record a c t u a l s c a n d a t e
+G
VCR s t a r t time
* VCR s t o p time o n l yn e e d st ob er e c o r d e d
(mm/dd/yy)
participant on the tape
+H
initial
Sonographer I D #
Sonographer
Impression:
P
F
G
E
when t h e l a s t
i s scanned.
-
Poor
- Fair
- Good
- Excellent
+I
L i s t QC s i t e scanned
+J
L i s t t r a c k i n gi m p r e s s i o n .I fn ot r a c k i n g
+K
Yes/No.
+L
Any i n f o r m a t i o n p e r t i n e n t t o i n t e r p r e t a t i o n o f i m a g e s
ox
followingflowofscan,equipmentproblems,
or imagingproblem,
etc.
+
i s done, l i s t r e a s o n .
L i s t sites notcompleted.
RepeatCodes
-
1. A c t u a l r e p e a t s c a n s o f
thelogsheetonly.
2.
a s i t e need t o b e i d e n t i f i e d
on
I f a code is r e p e a t e d b e c a u s e t h e
select footswitch
was n o t p r e s s e d t o a d v a n c e t h e f l o w c h a r t , n o t e o n t h e
l o g s h e e tt h e circumstances. The s i t e s d on o t need t o
b er e p e a t e d .
Once i d e n t i f i e d ,t h e URC w i l l c o r r e c t
t h e f i l e t o match t h e i m a g e s o n t a p e .
S t a r t i n g Date andShipping
,Beginning Shipping
follows:
Number
Numbers f o r e a c h f i e l d c e n t e r
F o r s y t h ARIC/FHS:
J a c k s o n ARIC:
Minneapolis A R I C / F H S :
are as
FU3001
JU3001
Mu3001
ARIC PROTOCOL 6a.UltrasoundScanningProcedures
- Visit
3 VERSION 3.0 0 1 / 9 5
A - 8
Hagerstown AFiIC:
WU3001
-
Loginreport t o FieldCenter
t h i s report a c k n o w l e d g e s t h e
is completefortheLogin
receiptofstudiesandprocessing
p r o c e d u r e sT
. his
report is s e n w
t eekly.
T h e s o n o g r a p h e r sc a n
delete t h e s t u d i e s ' l i s t e d from t h e s t u d i e s d i r e c t o r y on t h e i r
PC. Thisneeds. t o bedoneweekly
t o p r e v e n th a r dd r i v ed i s k
space problems.
ARIC PROTOCOL 6 a .U l t r a s o u n dS c a n n i n gP r o c e d u r e s
-
V i s i t 3 V E R S I O N 3.0 01/95
A - 9
LOQ SHEET
-W
+N
ARIC PROTOCOL 6a. U l t r a s o u n dS c a n n i n g
h
Procedures
- Visit
3 VERSION 3 . 0 0 1 / 9 5
I
PLACE CASSETTE
ImlEN
AND
or
I
OEIS
LABEL
I
-
l l
, ,?dl
-IL.
SUPER VIiS CASSETTE LABELING
1
CASSETTE LABEL
DlllECflON
LABELS
10
rACE
(I)
4
/
PLACE CASSETTE &
PAnTICIPANT
’*-
0
“
_
TOP
I-IEnE..PAnTICIFANTS
I N SAME onoEn AS
O N CASSETTE
,,-
BOTTOM QOES
INTO DISK D n w
TtllS SIDE UP
3 112 INCH DISK LABELING
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
,
~
.., . ...
.
,
,
-
Visit 3 VERSION 3.0 01/95
A
-
10
APPENDIX VI:
VIDEO CASSETTE AND DISKETTE LABELING DIAGRAM
V
"_
Super VtIS
._".
-SVtI!
_.."_
cIc9E.
11119
1
SIM
Or
CASE
LABEL
i
SUPER VHS CASSETTE LABELING
>
I
I
CASSETTE LABEL
_-
f
.
PLACE CASSETTE L
PAl7TICIPANT
LABELS
,
I4El7E..PAnTICIFANTS
4-
TOP
IN SAME o n m n AS
ON CASSETTE
\
f-
BOTTOM QOES
INTO DISKDnwE
TttlS SIDE UP
3 1/2 INCH DISK LABELING
-
ARIC PROTOCOL 6a. Ultrasound'scanning Procedures
Visit 3 VERSION 3.0 01/95
A
- 11
T O P
ARIC PROTOCOL 6a. Ultrasound'Scanning Procedures
- Visit
3 VERSION 3.0 01/95
A
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12
APPENDIX VI18
WEEKLY SHIPPING LOG
WEEKLY SHIPPING LOG
SBIPPIXG LOG
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit
3 VERSION 3,O 0 1 / 9 5
A
APPENDIX VIII:
I.
-
13
INFORMATION REFERENCE SHEET
List of contact personnel when experiencina eauipment or procedure
failure durina the ultrasound
scan.
Before contacting the individual
by phone, make a list of the apecific
symptom, include the datesymptom started and date service
problem
was requested. Fax this list to your contact person and fax a copy t o
the URC attention Delilah
Cook, Chief Reader and Carolyn Bell login.
Follow-up o n service by sending a summary of results by computer
network mail, U.S. mail, or fax (preference of the field center)
to
URC
--
-
.
1.
Biosound
Fax # 317-841-8616
800-428-7378
Phase 2 Unit
a
Bob Nitch
Dave Struewing
Mike Meador
2.
URC
Fax # 919-759-2139
919-759-2137
-
Peripheal Equipment
Sonographer box, attached foot switches and cables, ultrasound
software, the arterial tracker
and transducer arm (at centers
where applicable).
Sonographer certification and training, and data flow
Kathy Joyce, Administrative Secretary who will direct call asfollows:
-
Delilah Cook
Protocol procedure, Sonographer Training and Data Flow,
or equipment problems
Carolyn Bell
Login and Distensibility
Pam Wells or Delilah Cook Sonographer Certification and Review
--
3.
-
Dell Computers
Damian
Brown
800-284-1200
or
ext. 3967
local compouter repair facility
4.
Dinamap
Johnson & Johnson Critikon
Pam Thornbury
800-255-2500 or 919-852-2733
5.
Oscilloscope
Tektronix
700 Professional Drive
Gathersburg, Maryland 20879
6.
Strip
Chart
Recorder
ARIC PROTOCOL 6a. Ultrasound
MFE Instruments
John Lepore
800-472-4633 Fax # 508-921-9110
-
Scanning Procedures Visit 3 VERSION 3.0 01/95
11.
Miscellaneous EsuiDment Information
--
1.
Dinamap
calibration and alarm settings are Pre-set at the
factory and do not need any action from the sonographer
factory settings are acceptable for our
purpose.
2.
S-VHS tape
--
-
Do not purchase "Sony" brand tapes because the
NEC-VCR
is very sensitive and does not operate properly with this
brand. Due to storage limitationat the URC, the Fuji tape has
been tested and is recommended for this study.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
-
Visit 3 VERSION 3.0 01/95
A
APPENDIX IX:
"The
- 15
READING LIST
Language of Anatomy"
From: Gardner, W.D. & Osburn, W. A. (1973) Structureof the Humaq
Bodv. (2nd ed.) Philadelphia: W.B. Saunders Company.
"Angiology"
From: Williams, P.L. and Warwick, R., eds. (1980) Gray's Anatomv.
(36th ed) Philadelphia: W.B. Saunders Co.
"Blood
Supplyto the Head and Neck"
From: Fried, L.A. (1976) Anatomv of the Head, Neck, Face,and Jaws.
Philadelphia: Lea f Febiger.
"Systemic and Pulmonary Circulations"
S.L., Woods, S.L., Sivarajan, E.S. and Halpenny.
From:Underhill,
Co.
C.J., eds. (1982) Cardiac Nursinq. Philadelphia: J.B. Lippincott
"Pathogenesis of Atherosclerosis"
From: Cardiac Nursinq.
"The
Carotid Plaque"
From: Robicsek, F. Ed. (1986) Extracranial Cerebrovascular
Diasnosis and Manauement. NY: McMillan Publishing.
Disease
Diasnostic Ultrasound, Principles, Instruments, and Exercises by Frederick
W.
Kremkau, Ph.D. Third Edition Publisher: W. B. Saunders Company
Harcourt Brace Jovanovich,
Inc.
Chapter 1 from Diasnostic Ultrasound;
Frederick W. Kremkau, Ph.D. 3rd edition.
Chapter
2,
pages
9-30
in Diasnostic Ultrasound.
Chapter 2, pages 41-45 of Diaunostic Ultrasound.
Chapter
3of Diaunostic Ultrasound.
Chapter 4 pages 105-114 and pages 130-137-of
Diaunostic Ultrasound.
"HOW a
B-Mode Image is formed
- A Summary".
Chapter 5 in Diasnostic Ultrasound.
Article, "Artifacts in Ultrasound Imaging" (Kremkau
& Taylor)
Chapter 6 in Diaunostic Ultrasound. Skip Section 6.3.
Chapter 7 in Diaunostic Ultrasound. Skip Section 7.3.
ARIC PROTOCOL 6a.
-
Ultrasound Scanning Procedures Visit 3 VERSION 3.0
01/95
A
-
16
Pignoli, P., Termoli, E., Poli, A., Oreste, P., Paoletti, R. (1986)
"Intimal Plus Medial Thicknessof the Arterial Wall: A Direct
Measurement with Ultrasound Imaging." Circulation. 74 (6), 1399-1406.
Fact Sheet on Heart Attack, Stroke, and Risk Factors.
(1987) American Heart Association. Dallas, TX.
Pages 132-143 "Coronary Artery Disease Risk Factors"
From: Cardiac Nursinq
Coronary Risk Factor Statement to the American
Public.
(1987) American Heart Association. Dallas, TX.
Grundy, S.M. (1986) Cholesterol and coronary heart
(20) 2849-2858.
Eron, Carol (1988) Young hearts.
Science News.
disease.
JAMA.
256
134, 234-236.
Stamler, J., Wentworth, D. t Neaton, J.D. (1986) "Is the Relationship
Netween Serum Cholesterol and Risk
of Premature Death From Coronary
Heart Disease Continuous and Graded?" JAMA. 256 (20) 2823-2828.
Enos, W.F.,
Holmes, R.H. & Beyer, J. (1953) "Coronary Heart Disease
Among United States Soldiers Killedin Action in Korea: A Preliminary
JAMA. 152, 1090-1093.
(Reprinted 1986 JAMA 256 (20).
Report."
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit
3 VERSION 3.0 01/95
A
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17
"High ResolutionB-Mode Ultrasound Scanning Methodsin the
Atherosclerosis Risk in Communities Study
(ARIC)", M.G. Bond et al.
Journal of Neuroimaging, Vol 1, No 2 , May 1991, pages 68-73.
"High Resolution B-Mode Ultrasound Reading Methodsin the
Atherosclerosis Risk in Communities (ARIC) Cohort, Ward
A. Riley, et
al. Journal of Neuroimaging, Vol 1, No 4 , November 1991, pages 168172.
"An Approachto the Noninvasive Periodic Assessment
of Arterial
Elasticity in the Young"Riley, Barnes and Schey. Preventive Medicine
13, 169-184 (1984)
"Ultrasonic Measurement of the Elastic Modulusof the Common Carotid
Artery: The Atherosclerosis Risk in Communities (ARIC)Study".
Accepted by Stroke, 1992.
ARIC PROTOCOL 6a. Ultrasound Scanning Procedures
- Visit
3 VERSION 3.0 01/95