Pannus Assistance Needed for Obstetric Ultrasound Studies: A Randomized Controlled Trial
Phase: NA
Conditions: Obesity Complicating Childbirth, Fetal Anomaly
Sponsor: Prisma Health-Upstate

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Pannus Assistance Needed for Obstetric Ultrasound Studies: A 
Randomized Controlled Trial 
NCT05764408 
Protocol 
(Version 1.0, 02.03.2023) 
 
 

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TABLE OF CONTENTS 
Protocol…………………………………………………………………………………………………………………………………… 1 
1 Introduction……………………………………………………………………………......................................... …… 3 
    1.1 Abstract……………………………………………………………………………………………………………………………… 3 
    1.2 Specific Aims………………………………………………………………………………………………………………………. 3 
 
    1.3 Purpose of the Protocol……………………………………………………………………………………………………… 3 
2 Background…………………………………………………………………………………………………………………………… 4 
    2.1 Introduction……………………………………………………………………………………………………………………….. 4 
       2.1.1 Obesity’s Impact on Obstetric Ultrasound……………………………………………........................... 4 
       2.1.2 Previously Attempted Solutions……………………………………………………………………………………. 4 
       2.1.3 Conclusions from Pilot Study…………………………………………………………………………................. 5 
    2.2 Rationale for Clinical Trial…………………………………………………………………………………………………… 5 
3 Study Design…………………………………………………………………………………………………………................. 6 
 
    3.1 Research Questions……………………………………………………………………………………………………………. 6 
    3.2 Design Summary………………………………………………………………………………………………………………… 6 
    3.3 Eligibility Criteria………………………………………………………………………………………………………………… 6 
       3.3.1 Inclusion Criteria…………………………………………………………………………………………………………… 6 
       3.3.2 Exclusion Criteria………………………………………………………………………………………………………….. 7 
 
4 Study Procedures…………………………………………………………………………………………………………………. 8 
    4.1 Screening…………………………………………………………………………………………………………………………… 8 
    4.2 Randomization and Masking……………………………………………………………………………………………… 8 
    4.3 Intervention Implementation…………………………………………………………………………………………….. 8 
    4.4 Baseline Procedures…………………………………………………………………………………………………………… 8 
 
    4.5 Study Visits / Follow-Up……………………………………………………………………………………………………… 9 
       4.5.1 Withdrawals……………………………………………………………………………………………………............... 10 
    4.6 Outcome Measures……………………………………………………………………………………………………………. 10 
       4.6.1 Primary Outcomes………………………………………………………………………………………………………… 10 
       4.6.2 Secondary Outcomes……………………………………………………………………………………………………. 10 
 
    4.7 Reportable Adverse Events.……………………………………………………………………………………………….. 11 
5 Statistical Considerations……………………………………………………………………………………………………… 12 
 
    5.1 Sample Size and Power………………………………………………………………………………………………………. 12 
    5.2 Analysis Plan……………………………………………………………………………………………………….................. 12 
 
    5.3 Data Processing………………………………………………………………………………………………………………….. 12 
6 Study Administration……………………………………………………………………………………………………………. 13 
 
Appendix A-D  
 
 
 
 
 
 
 
 
 
14 
References 
 
 
 
 
 
 
 
 
 
 
18 
 
 

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1. Introduction 
1.1 Abstract 
Pannus Assistance Needed for Obstetric Ultrasound Studies (PANOUS) is a single-center randomized 
controlled trial to determine whether pannus retractor adhesive use improves completion rates of 
sixteen prespecified fetal anatomy ultrasound components among pregnant patients with body mass 
index (BMI) ≥40 kg/m2 and a pannus. One hundred fifty participants will be randomized in a 1:1 fashion 
to control (no retractor) or intervention (retractor) group during their midtrimester detailed anatomy 
ultrasound. The primary outcome will be completeness of the detailed ultrasound, measured by 16 
prespecified views from the anatomic survey. The secondary outcomes include survey responses 
measuring participant and sonographer experience, completeness of all ultrasound views, detection of 
fetal anomalies, skin to amniotic cavity depth, duration of ultrasound exam, and an assessment of the 
incidence of adverse outcomes in both treatment groups. 
 
1.2 Specific Aims 
Primary Research Aim: 
AIM 1: Determine whether pannus retractor adhesive use improves completion rates of sixteen 
prespecified fetal anatomy ultrasound components among pregnant patients with BMI ≥40 kg/m2 and a 
pannus.  
 
Secondary Research Aims: 
 
 
AIM 2: Evaluate whether pannus retractor adhesive use improves sonographer pain perception during 
the fetal anatomy ultrasound evaluation of pregnant patients with obesity and a pannus. 
 
 
AIM 3: Evaluate whether pannus retractor adhesive use improves patient satisfaction regarding fetal 
anatomy ultrasound image quality. 
 
 
1.3 Purpose of the Protocol  
The protocol describes the background, design and organization of the study. It represents a written 
agreement between study investigators. A similar version of this protocol is reviewed by the 
Institutional Review Board at the study site prior to recruitment.  
 
 

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2. Background 
2.1 Introduction 
Pregnancies complicated by obesity have an increased risk of multiple pregnancy complications 
including structural fetal anomalies [1-3]. Therefore, obesity in pregnancy (BMI ≥30 kg/m2) is an 
indication for a detailed anatomic ultrasound examination [4]. Ultrasound is a critical tool for the 
detection of congenital anomalies; however, obesity makes ultrasound examinations technically 
challenging [5]. Specifically, the ability to detect structural fetal anomalies by ultrasound significantly 
decreases as maternal body mass index (BMI) increases [6]. The American College of Obstetricians and 
Gynecologists (ACOG) recommends that patients with obesity are counseled on the limitations of 
ultrasound to detect structural anomalies [7].  
 
2.1.1 
Obesity’s Impact on Obstetric Ultrasound 
Several studies have evaluated completion rates of ultrasound exams for patients with obesity, all 
showing a similar trend: patients with normal BMI achieve a complete ultrasound 58-79% of the time, 
while patients with BMI ≥40 kg/m2 have complete ultrasounds just 10-56.2% of the time [8-11]. Other 
studies have focused on aspects of the ultrasound examination other than completion. Yaqub et al. 
demonstrated a statistically significant decrease in image quality scores with increasing BMI, Gupta et al. 
showed that the ultrasound examination took 8.9 minutes longer for patients with BMI of 40 or greater 
compared to normal BMI, and Hendler et al. found a linear correlation between increasing BMI and 
decreasing visualization of fetal heart and spine views [12-14]. 
 
It should also be noted that the presence of obesity does not only impact pregnant patients and their 
fetuses, but also sonographers. Additional pressure and manipulation are needed to accomplish 
ultrasounds when obesity is present, placing increased mechanical strain on sonographers. It has been 
documented that obstetric/gynecologic (OB/GYN) sonographers report pain during ultrasound exams 
66-67% of the time [15, 16]. There is also significant risk for sustaining a work-related injury, reported in 
48.15% of OB/GYN sonographers [16].  
 
2.1.2 
Previously Attempted Solutions 
Numerous studies have evaluated techniques to improve visualization and completion of obstetric 
ultrasound for patients with obesity. The Sims technique uses unique patient and ultrasound probe 
positioning to decrease the distance from skin to amniotic cavity [17]. Others advocate for patient 
engagement with physical modifications like holding up their pannus to optimize ultrasound imaging 
[18]. Puissegur et al. graded ultrasound image quality when standard ultrasound settings were applied 
versus customized settings chosen by sonographers; they concluded that the quality of ultrasound 
images was improved when customized settings were allowed [19]. Other studies have tried adding an 
early ultrasound or delaying the timing of the midtrimester ultrasound for patients with obesity [20-23]. 
Despite these efforts, completion rates of anatomic surveys for patients with obesity remain lower than 
those for patients without obesity. 
 
 

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2.1.3 
Conclusions from Pilot Study 
We recently completed a pilot study investigating a novel approach for this issue, entitled Pannus 
Retraction for Ultrasound Evaluation of the Obese Gravida: A Pilot Study. Twenty prospective 
participants with a BMI of at least 40 kg/m2 were enrolled to have a pannus retractor adhesive in place 
at the time of detailed anatomic ultrasound. This study confirmed that recruitment, enrollment, and 
intervention implementation are feasible for the same population and study setting that we intend to 
use for this randomized controlled trial. The pilot study was not adequately powered to assess 
differences in completion rates for ultrasounds with pannus retractor adhesive use. The noted 
completion rate was 38% in patients with a pannus and BMI ≥40 kg/m2, compared to a retrospective 
completion rate of 23% for those with a BMI ≥40 kg/m2 collected over 6 months prior to the trial. 
 
2.2 Rationale for Clinical Trial 
In summary, pregnant patients with obesity have more limited ultrasound exams when compared to 
patients with a normal BMI. Decreased ultrasound completion rates translate into significant maternal 
and neonatal risks as the ability to detect structural fetal anomalies by ultrasound significantly decreases 
as maternal BMI increases [6]. Despite the many strategies that have been attempted in effort to 
resolve this issue, fetal anatomic ultrasound examination remains negatively affected by obesity. This 
study seeks to test a novel approach to improve completion of the anatomic survey for pregnant 
patients with obesity, supported by recent pilot study completion. 
 
 

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3. Study Design 
3.1 Research Questions 
Question 1: Does the use of a pannus retractor adhesive increase the rate of detailed anatomic survey 
completion, defined by satisfactory visualization of sixteen prespecified fetal anatomy views, for 
participants with a pannus and body mass index greater than or equal to 40 kg/m2?  
Hypothesis 1: Pannus retractor adhesive use improves completion of sixteen prespecified fetal 
anatomy ultrasound components. 
 
Question 2: Does the use of a pannus retractor adhesive improve sonographer pain during the fetal 
anatomy ultrasound evaluation of pregnant patients with a pannus and body mass index greater than or 
equal to 40 kg/m2?  
Hypothesis 2: Pannus retractor adhesive use improves sonographer-experienced pain during the 
fetal anatomy ultrasound. 
 
Question 3: Does pannus retractor adhesive use improve patient satisfaction regarding fetal anatomy 
ultrasound image quality?  
Hypothesis 3: Pannus retractor adhesive use improves patient satisfaction regarding fetal 
anatomy ultrasound image quality. 
 
3.2 Design Summary 
This is a pragmatic randomized controlled trial that will be conducted and reported in concordance with 
the Consolidated Standards of Reporting Trials guidelines [24]. One hundred fifty participants will be 
enrolled and randomized to the control group (no retractor) or intervention group (retractor) at a 1:1 
ratio. The randomization sequence will be generated by the study statistician using a permuted block 
design. Investigators will be masked to the randomization sequence and variabler block sizes.  Study 
participants, sonographers and attending physician will not be masked. The ultrasound examinations 
will be performed according to usual office protocols for a detailed anatomic ultrasound. Participants 
allocated to the intervention group will initially undergo pannus retractor adhesive placement with fetal 
evaluation below the pannus. Upon completion of this, the adhesive will be removed, and other 
transabdominal or transvaginal imaging will be performed as per routine. The adequacy of ultrasound 
visualization will be compared between the two groups. Sonographer and participant survey responses 
will be compared between the two groups. 
 
3.3 Eligibility Criteria 
3.3.1 
Inclusion Criteria 
Pregnant patients presenting for anatomy ultrasound with: 
• 
Age of 16 or older 
• 
English or Spanish language 
• 
BMI of at least 40.0 kg/m2 , calculated within 6 months of conception or at the first obstetric visit 
• 
Pannus grade ≥1 (per the scale reported in 4.4 Baseline Procedures) 

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• 
Gestational age between 18 weeks 0 days to 23 weeks 6 days, confirmed by prior ultrasound 
assessment 
 
3.3.2 
Exclusion Criteria 
• 
Patients who have already had a routinely timed anatomy ultrasound during the same pregnancy 
with Prisma Health Maternal-Fetal Medicine  
• 
Patients with a known major fetal anomaly, confirmed by Prisma Health Maternal-Fetal Medicine 
• 
Tape/adhesive allergy 
• 
Multifetal gestation 
• 
Intrauterine fetal demise 
 

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4. Study Procedures 
4.1 Screening 
Medical records of all potential participants scheduled for an anatomic ultrasound will be screened by 
trained research coordinators or study investigators. The research team will attempt to contact 
potential participants who satisfy inclusion and exclusion criteria to determine willingness to participate 
prior to the ultrasound appointment. If the research team is unable to reach potential participants prior 
to the ultrasound visit, they will be approached for study enrollment when they arrive in the office for 
their scheduled ultrasound visit. A screening log will be used to track all patients approached for the 
study. Once a potential participant arrives to the ultrasound office, full informed consent will be 
obtained. The presence of a pannus will be confirmed through visual assessment. Those who do not 
have a pannus will not randomized to a study arm. Those who meet the full set of inclusion and 
exclusion criteria will then be randomized to control or intervention arm. The graphics in Appendix A 
and B may be shown to potential participants as a component of the recruitment and consenting 
process. 
4.2 Randomization and Masking 
One hundred fifty participants will be randomized to the control group (no retractor) or intervention 
group (retractor) at a 1:1 ratio. The randomization sequence will be confidential and computer-
generated by the study statistician using a permuted block design. Investigators will be masked to the 
randomization sequence and variable block sizes.  Study participants, sonographers and attending 
physicians interpreting the ultrasound will not be masked. 
4.3 Intervention Implementation 
traxi® Panniculus Retractor (Laborie, Portsmouth, NH) is a disposable adhesive medical device designed 
for surgical patients with a BMI of at least 30kg/m2. The adhesive retracts the pannus cephalad and 
exposes the lower abdomen. The device is similar to a large sticker or bandage, posing no more than 
minimal risk to participants. The adhesive will be applied to the abdomen immediately prior to a 
participant’s scheduled ultrasound and will occur according to manufacturer instructions (see Appendix 
A). The adhesive’s instructions for application are straightforward for study personnel and sonographers 
to follow without additional training needed. Sonographers will proceed with the ultrasound exam per 
usual protocol. Once the ultrasound exam has ended, the adhesive will be immediately removed and 
discarded. 
4.4 Baseline Procedures 
1. 0-15 weeks before scheduled ultrasound: potential participants will be contacted to identify 
willingness to participate.  
2. Fifteen minutes prior to the ultrasound: The participant will be taken to an exam room at the 
office. The study will be explained, and informed consent will be obtained. Baseline 
demographic and medical history will be collected from the participant’s chart, including:  
weight/BMI at first obstetric visit during this pregnancy and in the 6 months leading up to 

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pregnancy, gestational age, parity, diabetic status, insurance status, smoking status, cesarean 
delivery history, and prior other abdominal surgical history. Race and ethnicity will be verbally 
collected from participants’ self-report. Waist circumference will be recorded.  
3. Ultrasound: The participant will be taken to the ultrasound exam room. The presence of a 
pannus will be confirmed. The grade of pannus will be evaluated in a reclined, supine position 
like what will be used for the ultrasound exam. It will be classified according to the following 
system described by Iglesias et al.: no pannus (grade 0), pannus remaining above the inguinal 
ligament (grade 1), overhanging pannus below the inguinal ligament but not surpassing the 
upper third of the thigh (grade 2), overhanging pannus located within the middle third of the 
thigh (grade 3), overhanging pannus within the lower third of the thigh (grade 4), overhanging 
pannus below the knee (grade 5) [25]. The presence of fetal cardiac activity will be confirmed 
with ultrasound. Once all eligibility criteria have been satisfied, randomization will occur. Using 
only the minimal amount of pressure to create the image, the shortest mid-sagittal distance will 
be measured from the skin to the amniotic cavity above and below the pannus.  
A.    Intervention group: Research team members, with or without assistance from the 
sonographer, will apply the pannus retractor adhesive according to manufacturer’s 
directions. This will be performed with the patient in supine position. The same ultrasound 
depth measurement will be repeated once the pannus has been retracted. The ultrasound 
will then proceed in usual fashion. The sonographer will be asked to attempt all views of the 
detailed anatomic survey before the adhesive is removed. If the sonographer thinks that 
additional views could be obtained with the adhesive removed using transabdominal or 
transvaginal imaging, this is acceptable based on the pragmatic design of this study. The 
start and end time for evaluation of fetal anatomy will be recorded, along with the length of 
time that is needed for retractor application.  
B.    Control group: the detailed anatomic survey will proceed per normal protocol. 
Approaches may include transabdominal and transvaginal imaging. The start and end time 
for evaluation of fetal anatomy will be recorded. 
4.  Immediately after the ultrasound: The participant and sonographer will fill out surveys about 
their experience. These will be completed directly through REDCap, utilizing an electronic tablet 
for entry.  
5. After the ultrasound: The ultrasound report will be completed by the Maternal-Fetal Medicine 
attending physician per normal protocol. The research team will subsequently review the report 
and abstract pertinent outcome data.  
 
4.5 Study Visits / Follow-Up 
Study participation will be completed when the participant’s ultrasound visit concludes. No additional 
visits or study follow-up is planned.  
 
 
 

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4.5.1 Withdrawals 
Participants who withdraw from the study after randomization will be excluded from further data 
collection. Outcomes ascertained up until the time of withdrawal will be reported in intent to treat 
fashion.  
4.6 Outcome Measures 
4.6.1 Primary Outcome 
• 
Specific aim 1 will be assessed by comparing the proportion of patients with adequate 
visualization of sixteen prespecified fetal anatomy ultrasound components: brain (lateral 
ventricles, cerebellum, cavum), face, heart (four chamber view, right outflow tract, left outflow 
tract, three vessel view, three vessel trachea view), spine (cervical, thoracic, lumbar, sacrum, 
and spine shape will be summarized as one spine view), ventral wall, umbilical cord, stomach, 
left and right kidneys, and bladder. 
o A view is considered adequate if the interpretation from the ultrasound report is 
“normal/within normal limits,” “present,” “visualized,” “seen,” or an abnormality is 
visualized.  
▪ 
All individual portions of the spine views must be labeled as above for the 
overall spine visualization to be considered adequate. 
▪ 
For the “umbilical cord” field, “3 vessel cord” or a visualized abnormality such as 
“2 vessel cord” will be considered adequate visualization. 
o A view is considered inadequate if the interpretation is “limited views,” “color only,” 
“not seen,” or “limited normal views.” 
 
4.6.2 
Secondary Outcomes 
• 
Sonographer experience 
o Specific Aim 2 will be assessed by comparing sonographer pain as reported on Question 
#1 on the Sonographer Survey (Appendix C).  
o Average Likert scale response will be compared between groups. 
▪ 
Responses to questions 1 and 2 will be interpreted with 1 signifying the best 
experience and 5 signifying the worst experience. 
▪ 
Responses to questions 3, 4, and 5 will be interpreted with 1 signifying the worst 
experience and 5 signifying the best experience.  
• 
Participant experience 
o Specific Aim 3 will be assessed by comparing participant satisfaction with image quality 
as reported on Question #2 on the Participant Survey (Appendix D).  
o Average Likert scale responses will be compared between groups.  
▪ 
Responses will be interpreted with 1 signifying the worst experience and 5 
signifying the best experience. 
• 
The proportion of patients with adequate visualization of all anatomy views within the 
ultrasound report will be compared between groups, views including: calvarium/cranium, 

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intracranial anatomy, cavum, parenchyma, lateral ventricles, choroid plexus, cerebellum/vermis,  
cisterna magna, midline falx, cervical spine, thoracic spine, lumbar spine, sacral spine, spine 
shape/curvature, face, lips, neck, nuchal fold, nasal bone, palate, profile, orbits/eyes, mandible, 
maxilla, thoracic contour, lungs, four chamber view, cardiac activity, cardiac rhythm, cardiac 
situs, right outflow tract, left outflow tract, aortic arch, ductal arch, SVC, interventricular 
septum, cardiac axis, diaphragm, three vessel view, three vessel trachea view, IVC, crossing, 
ventral wall, cord insertion, situs, stomach, gallbladder, left kidney, right kidney, bladder, left 
humerus, right humerus, left forearm, right forearm, left hand, right hand, left femur, right 
femur, left lower leg, right lower leg, left foot, right foot, umbilical cord, genitalia 
o Adequacy of interpretation will be followed as described above under the primary 
outcome.  
o For the “genitalia” field, “male,” “female,” or “normal/within normal limits” will be 
considered adequate visualization.  
• 
The proportion of participants with detected fetal anomalies will be compared between groups. 
o The ultrasound reports’ individual fields and summary will be reviewed to determine if a 
fetal anomaly was suspected or confirmed during the encounter. The name of the 
anomaly or anomalies will be recorded.  
• 
Skin to amniotic cavity depth 
• 
Duration of ultrasound exam 
• 
Adverse events, compared between groups. The specific events we plan to report as an 
outcome include: 
o Skin irritation 
o Allergic reaction 
o Maternal intolerance of pannus retractor adhesive (intervention group only) 
o Fetal demise 
o Hospital admission immediately following the ultrasound examination 
 
4.7 Reportable Adverse Events 
This study does not pose more than minimal risk to participants. Investigators will monitor participants 
for any adverse event during participation, as defined by the U.S. Department of Health and Human 
Services Office for Human Research Protections 2007 guidance documents (45 CFR part 46). The above 
list of adverse events will be studied as an outcome, but any adverse event will be reported promptly to 
the IRB. 
 
 

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5. Statistical Considerations 
 
5.1 Sample Size and Power 
 
A retrospective review of detailed anatomic ultrasound examinations at our institution confirmed that 
ultrasound completion rates decrease with increasing BMI, consistent with literature review. 
Specifically, a subset of sixteen anatomy views were successfully visualized in 23% of patients with a BMI 
≥40 kg/m2. One hundred and thirty-two patients randomized in a 1:1 ratio provides 80% power to detect 
a two-fold improvement in the primary outcome assuming a baseline completion rate of 23% and a two-
sided alpha of 0.05. To account for an attrition rate after initial enrollment of over 10%, this calculation 
will be inflated to a target sample size of 150 participants.  
 
It is anticipated that some participants who meet study inclusion criteria by chart review will not have a 
pannus and therefore not meet full criteria for inclusion. Some patients may also be diagnosed with an 
intrauterine fetal demise on the day of the examination and would be excluded. Those who do not have 
a pannus and/or get diagnosed with an intrauterine fetal demise will give consent for the study but not 
be randomized or included for analysis. In the pilot study, 10% of participants who met BMI criteria did 
not have a pannus. We will inflate that to 20% and therefore plan to consent up to 180 participants to 
reach the 150 who meet criteria for randomization. 
This sample size is not expected to be adequately powered for determination of a difference in fetal 
anomaly detection or for the other secondary outcomes.  
 
5.2 Analysis Plan 
 
We will compare the characteristics of participants between groups using descriptive statistics to 
examine the success of randomization. Outcome data analysis will follow the intention-to-treat 
principle. The primary outcome for Aim 1 (the completion rate of sixteen prespecified fetal anatomy 
ultrasound components) will be compared between the intervention group and the control group by 
two-proportion Z-test and risk ratio. The outcomes for Aims 2 (sonographer pain perception) and 3 
(patient satisfaction) will be compared using Student’s t-test and risk ratios. Affiliates at Clemson 
University will assist with data analysis.  
 
 
5.3 Data Processing 
Data will be collected from the electronic medical record, during the research visit prior to the 
ultrasound, from the ultrasound imaging and reporting software, and from surveys. All data fields will be 
directly entered into a password-protected REDCap database. This will occur at the point of contact with 
the study participant, other than data input for the ultrasound report. The report is completed at a 
variable timepoint after the participant encounter. Once it is complete, relevant fields will be entered 
into REDCap. 
 
 

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6. Study Administration 
This study will take place within one department, Prisma Health – Upstate Maternal-Fetal Medicine. The 
study will take place at two office locations within this department:  
 
Prisma Health Maternal-Fetal Medicine – Faris Rd 
890 W Faris Rd #420, Greenville, SC 29605 
 
Prisma Health Maternal-Fetal Medicine – Anderson 
2000 E Greenville St #4600, Anderson, SC 29621 
 
The following personnel will be participating with the described roles, from Prisma Health: 
 
Daniel Pasko, MD 
Senior Investigator 
Melissa Wise, MD 
Principal Investigator 
Amy Crockett, MD 
Sub-investigator 
Andrew Lane, MD 
Sub-investigator/Medical Director – Ultrasound 
Laura Carlson, MD 
Sub-investigator 
Patti Parker, BSN, RN 
Sub-investigator/Manager of Clinical Trials Research 
Jessica Britt, PhD 
Sub-investigator/Biostatistician 
Alexis Kelly, BS 
Sub-investigator/Coordinator 
Emma Klipstein, BSN 
Sub-investigator/Coordinator 
Katelyn Pratt, MD 
Sub-investigator 
Alison Kimura, MD 
Sub-investigator 
 
The following personnel will be participating with the described role, from Clemson University: 
 
Lu Zhang, PhD 
Sub-investigator/Biostatistician  
Marvin Okom, MBBS 
Sub-investigator/Biostatistician 
 
 
 

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APPENDICES 
 
A: Device Application Guide  
 

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B: Example of before and after application 
 
 
 
 

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C: Sonographer Survey 
You are invited to participate in a survey on your experience with a pannus retractor adhesive used at 
time of ultrasound. This is a research project being conducted by Daniel Pasko, a physician at Prisma 
Health. Your participation in this study will require the completion of the attached survey. This should 
take approximately five minutes of your time. This survey involves minimal risk to you. The benefits, 
however, may impact society by helping increase knowledge. 
 
You will not be contacted again in the future. You will not be paid for being in this study. Your survey 
answers will be maintained in REDCap database where data will be stored in a password protected 
electronic format. REDCap does not collect identifying information such as your name, email address, or 
IP address for this survey, though the ultrasound report that includes sonographer name will be 
collected from the patient participants. Your name would not be identified in any scientific publications 
or presentations.  
 
We will be happy to answer any questions you have about this study. If you have further questions 
about this project or if you have a research-related problem you may contact me, Daniel Pasko at 864-
455-1600. If you have any questions about your rights as a research participant, you may contact the IRB 
Administrator at 864-455-8997. The completion of this survey implies your consent to participate. Thank 
you! 
Rate your level of agreement with the following statements by checking one box for each 
row: 
 
Strongly 
disagree 
Disagree 
Neither 
disagree 
nor agree 
Agree 
Strongly 
agree 
Not 
Applicable 
1. I experienced pain in 
my arm, shoulder 
and/or wrist while 
performing this 
ultrasound 
 
 
 
 
 
 
2. The participant’s 
body habitus affected 
my ability to complete 
the ultrasound 
 
 
 
 
 
 
3. I feel confident about 
the quality of 
ultrasound images 
obtained 
 
 
 
 
 
 
4. The use of a pannus 
retractor made the 
ultrasound easier to 
perform 
 
 
 
 
 
 
5. It was easy to apply 
the pannus retractor 
 
 
 
 
 
 
 
Comments 
 
 

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D: Participant Survey 
Rate your level of agreement with the following statements by checking one box for each 
row: 
 
Strongly 
disagree 
Disagree 
Neither 
disagree 
nor agree 
Agree 
Strongly 
agree 
Not 
Applicable 
1. I felt comfortable 
during the ultrasound  
 
 
 
 
 
2. I am satisfied with 
the quality of 
ultrasound pictures I 
received 
 
 
 
 
 
 
3. I enjoyed the 
ultrasound experience 
today 
 
 
 
 
 
 
4. I would be willing to 
have future 
ultrasounds 
performed with the 
retractor adhesive in 
place 
 
 
 
 
 
 
Comments 
 
 
 
 
 
 
 
 
 
 

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