Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05001867 |
Other study ID # |
2017/3049 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2018 |
Est. completion date |
May 31, 2019 |
Study information
Verified date |
August 2021 |
Source |
Singapore General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Work-related musculoskeletal disorders (WRMSD) among sonographers/radiographers are prevalent
in the healthcare industry. This pilot study will evaluate the use of a robotic assisted
ultrasonography system (ROBUST) against the conventional abdominal ultrasound scanning
procedure. The ROBUST will be developed to provide 6 degrees of freedom to allow
radiographers to perform abdominal scanning without having to reach over patients.
10 sonographers with at least 5 years of experience will be recruited from SGH and SKH, to
perform abdominal ultrasound scans on healthy volunteers. Each sonographer will be randomly
assigned to scan a volunteer using conventional abdominal ultrasound scanning procedure and
with ROBUST respectively. The study will be done in 2 phases, separated by at least a 1-month
interval between scans.
Phase 1: Scanning of volunteer using conventional abdominal ultrasound scanning procedure.
Phase 2: Scanning of volunteer using ROBUST. Outcome measures will include ultrasound image
quality, sonographer feedback and comfort level as well as satisfaction feedback from healthy
volunteers. A panel of 4 reviewers, consisting of 2 radiologists and 2 senior radiographers
will be invited to grade the images, using a 3-point Likert scale. The duration of each
scanning will be recorded. The comfort level reported by sonographers will be assessed using
the SGH Comfort Level Survey. In addition, the comfort level of healthy volunteers will also
be assessed using a satisfaction questionnaire.
Description:
- 10 participating sonographers will be recruited from SGH and SKH to perform abdominal
ultrasound scanning.
- 10 healthy volunteers of average body habitus with BMI <30, abdominal circumference
<102cm will be recruited.
- Each sonographer will be randomly assigned to scan 1 healthy volunteer. The same
volunteer will be scanned twice with an interval of at least 1 month between two scans:
once using conventional abdominal ultrasound scanning procedure and once using ROBUST.
- During the session, markers coated with a retroreflective material to reflect light to
the motion capture camera will be pasted on participating sonographers on various parts
of the upper limb.
- Surface electromyography (sEMG) electrodes will be affixed on sonographers' upper
trapezius, deltoid, biceps, triceps, wrist extensors and flexors to monitor muscle
activities.
- The healthy volunteer will lie on a plinth with the participating sonographer seated
next to him/her. The sonographer will then perform scanning on various abdominal organs
following the point of reference and scanning approach as indicated.
- The same ultrasound scanner and probe type will be used on all volunteers by all
sonographers.
- Static bilateral grip strength of participating sonographers will be measured using a
dynamometer before and after each scan.
- At the end of both scans, participating sonographers will be required to complete a
survey on comfort level.
- At the end of both scans, healthy volunteers will be required to complete a survey on
satisfaction level.
- The quality of the images from both scans will be rated by 4 readers: 2 consultant
radiologists and 2 senior radiographers. A photometer will be used to ensure all readers
interpret images directly from a designated monitor under consistent lighting condition.