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Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST)

Sponsor
Singapore General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05001867
Collaborator
Sengkang General Hospital (Other), Servo Dynamics (Other)
20
Enrollment
2
Locations
12
Actual Duration (Months)
10
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST): a Pilot Study
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    May 31, 2019
    Actual Study Completion Date :
    May 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of quality of ultrasound image for manual scanning and robot scanning [During the scan]

    2. Kinematic data, Range of Motion from motion capture system [During the scan]

    3. Muscle activation from EMG data [During the scan]

    4. Static bilateral grip strength [Immediately before the scan and immediately after the scan]

    5. Questionnaire on comfort level from sonographers [immediately after the scan]

    6. Questionnaire on Satisfaction level from healthy volunteers [immediately after the scan]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Sonographer:

    -Experienced sonographers/ radiographers with more than 5 years of experience

    Healthy volunteer:

    • Inclusion criteria: - BMI <30

    • Abdominal circumference <102cm

    Exclusion Criteria:
    Sonographer:

    -Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury

    Healthy volunteer:

    -Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore General Hospital Singapore Singapore 169608
    2 Sengkang General Hospital Singapore Singapore 544886

    Sponsors and Collaborators

    • Singapore General Hospital
    • Sengkang General Hospital
    • Servo Dynamics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT05001867
    Other Study ID Numbers:
    • 2017/3049
    First Posted:
    Aug 12, 2021
    Last Update Posted:
    Aug 12, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Musculoskeletal Diseases

    Study Results

    No Results Posted as of Aug 12, 2021