Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST)
NCT ID: NCT05001867
Last Updated: 2021-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2018-06-01
2019-05-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
-Experienced sonographers/ radiographers with more than 5 years of experience
Healthy volunteer:
* Abdominal circumference \<102cm
Exclusion Criteria
-Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury
Healthy volunteer:
-Pregnancy
21 Years
80 Years
ALL
Yes
Sponsors
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Sengkang General Hospital
OTHER
Servo Dynamics
UNKNOWN
Singapore General Hospital
OTHER
Responsible Party
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Locations
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Singapore General Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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2017/3049
Identifier Type: -
Identifier Source: org_study_id
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