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

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

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.

Study Overview

• Status: Completed
• Conditions: Work-related Musculoskeletal Disorders

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 544886
    • SengKang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10 sonographers from SGH or SKH and 10 healthy volunteers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of quality of ultrasound image for manual scanning and robot scanning	During the scan
Kinematic data, Range of Motion from motion capture system	During the scan
Muscle activation from EMG data	During the scan
Static bilateral grip strength	Immediately before the scan and immediately after the scan
Questionnaire on comfort level from sonographers	immediately after the scan
Questionnaire on Satisfaction level from healthy volunteers	immediately after the scan

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Sengkang General Hospital; Servo Dynamics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 2017/3049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No