- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06576570
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
Study Overview
Status
Detailed Description
The study is working to identify actions of surgeons in the operating room that can contribute to work-related musculoskeletal disorders. This includes poor positioning and time spent in poor positioning while working in the operating room. The study is also looking to determine if fatigue plays a role in work-related musculoskeletal disorders.
Employing within-subject pre-post design to assess 1) patterns of aggregate risk data from video analysis in the OR for resident and attending surgeons over time and for different types of surgical tasks, 2) concurrent reliability assessment of the Rapid Upper Limb Assessment and Rapid Entire Body Assessment scores calculated from the software and visual analysis, 3) changes in pain data after review of the SOTER Task ergonomic outputs. The feasibility of using the system in the OR will also be assessed for open and laparoscopic surgery.
The study team will collect data, perform assessments, collect information from self-proctored surveys, and video record surgeon activities in the operating room on 20 surgeons. The video recordings will take measurements to assess risk factors for work-related musculoskeletal disorders. Following the fifth surgical case, the study team complete an education intervention by reviewing measurements established in the video recordings and supply a brief presentation on Ergonomics for Surgeons. A summary of observed body positioning for each subject is provided. Post intervention, five additional surgical cases will be observed in the manner of the previous cases to identify change in ergonomic risk.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- UF Health at Shands hospital
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Gainesville, Florida, United States, 32610
- UF Health Shands Hospital at the University of Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Any general surgery operative case by a surgeon from the Division of Acute Care Surgery. These cases will be conducted in what has been designated as the "Acute Care Surgery OR" for the day.
Exclusion Criteria:
- Any operative case in which the surgical attending or resident has not signed informed consent to record this individual during the case.
- Any operative case that the surgical attending feels is inappropriate for video recording or when filming could interfere with surgical procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Acute Care Surgery Attending and Resident Surgeons
Participants will be asked to perform their normal operative work for 5 cases while being filmed. Data will be collected using the SoterTask™ software which calculates momentary data on risk and an aggregate risk level. Two standard ergonomic risk assessments: Rapid Upper Limb Assessment (RULA) or the Rapid Entire Body Assessment (REBA) are also calculated. Both assessments are current best practice standard for determining the level of ergonomic risk. The RULA and REBA data calculated by SoterTask will be compared to scores assessed by the research team from the same video recordings of the work tasks. Following the fifth operative case, participants will view an educational presentation of surgical ergonomics and review the data summarized from the ergonomic measurement system with video of their movement with a visual guideline highlighting high-risk angles and movements including legs, arms, neck and back. |
During an individual meeting with participant, a brief presentation will be supplied for review.
Participant will view a video of their movements with a visual guideline highlighting high-risk angles and movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine Ergonomic Risk Through Video-based Analysis calculated by an artificial intelligence software and evaluator assessment of Rapid Upper Limb Assessment (RULA) and Rapid Entire Body Assessment (REBA)
Time Frame: 1 year
|
determine the ergonomic risk experienced by surgical attendings and residents during open and laparoscopic surgery measured through video-based analysis of
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Ergonomic Risk After Reviewing Video Capture and Risk Data
Time Frame: 1 year
|
determine if there is any change in ergonomic risk after reviewing video capture and risk data collated through artificial intelligence algorithms
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Efron, MD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202301655
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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