Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery

NCT06860048 | Completed

• 1 other identifier: 2022/ETH02203
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.

Conditions

Ergonomics

Outcome Measures

Primary Outcomes (1)

• Muscle fatigue

  Hand grip strength (muscle fatigue)was assessed at the beginning and at the two-hour mark during the robotic console component of the surgical case, using the Camry Electronic Handgrip Dynamometer (CAMRY model: SCACAM-EH101). The non-sleeve-wearing forearm acted as a control. During testing, the surgeon sat upright with the elbows flexed at right angles by the side of the body and hands in neutral positions (halfway between supination and pronation). The handle was pulled with maximum force for three seconds. The hand grip strength (measured in kg force) was recorded ten times for the dominant (right) and non-dominant (left) hands alternately.

  2 hours after intervention

Study Arms (1)

Arm sleeve

ACTIVE COMPARATOR

Randomised to wear arm sleeve on left or right

Device: Arm sleeve

Interventions

Arm sleeve DEVICE

Randomised to wear arm sleeve on left or right

Arm sleeve

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Robotic surgeon

Sponsors & Collaborators

• Prince of Wales Hospital, Sydney: lead

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 5, 2025
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)