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

Work-related Musculoskeletal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001867
• Other study ID #: 2017/3049
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Work-related Musculoskeletal Disorders

Locations

Country	Name	City	State
Singapore	Sengkang General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore General Hospital	Sengkang General Hospital, Servo Dynamics

Country where clinical trial is conducted

Singapore, 

Outcome

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