Evaluation of the Effectiveness of Robotic Assisted Ultrasonography System (ROBUST) in the Clinical Environment.

NCT04999475 | Completed

• 1 other identifier: 2019/2491
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Work-related musculoskeletal disorders (WRMSD) among sonographers/radiographers are prevalent in the healthcare industry. This 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. 6 sonographers with at least 5 years of experience will be recruited from SGH and SKH, to perform abdominal ultrasound scans on 50 patients. Patients will be screened by the radiographers in the study team for their suitability in the participation during their scheduled appointments and will be invited to undergo scanning with the ROBUST upon agreement. Outcome measures will include ultrasound image quality, sonographer feedback and comfort level as well as satisfaction feedback from patients. 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 to compare the images taken with ROBUST against the images taken conventionally prior to using the ROBUST. The duration of each session will be recorded. The comfort level reported by sonographers will be assessed using the SGH Comfort Level Survey. In addition, the comfort level of participating patients will also be assessed using a satisfaction questionnaire. The investigators hypothesize that there is no difference in imaging quality and comfort levels of sonographers and patients between a conventional ultrasound scan and scanning with the ROBUST. The investigators also hypothesize that there would be a reduction in the risk of WRMSD among sonographers with reduction in ergonomic risk factors.

Conditions

Abdominal Ultrasound Scanning

Outcome Measures

Primary Outcomes (3)

• Comparing Quality / Grading of ultrasound image for manual scanning and robot scanning

  through recruitment completion, an average of 3 months

• Comparing comfort level from sonographers for manual scanning and robot scanning

  through recruitment completion, an average of 1 month

• Comparing satisfaction level of patients for manual scanning and robot scanning

  after scanning completion, after 40 minutes

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients and Outpatients of Singapore General Hospital undergoing abdominal ultrasound scanning.

You may qualify if:

• Sonographer:
• Experienced sonographers/ radiographers with more than 5 years of experience
• Patient:
• BMI \<30
• Abdominal circumference \<102cm
• Independent Ambulation

You may not qualify if:

• Sonographer:
• With previously reported work-related or non-work related musculoskeletal discomfort or injury
• Patient:
• Pregnancy
• Non-compliance/difficulty in adhering to instructions (e.g. control breathing)
• No known muscular disorders

Sponsors & Collaborators

• Singapore General Hospital: lead
• Sengkang General Hospital: collaborator
• Servo Dynamics: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 10, 2021
• Study Start: June 1, 2019
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

SG (1)