Clinical trial NCT06576570: Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
Official title: Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Work Related Upper Limb Disorder
Musculoskeletal Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-subject pre-post design
Primary purpose: OTHER

Brief summary: 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 and whether an education intervention will change ergonomic risk.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 1 year
Secondary outcomes:
measure: Change in Ergonomic Risk After Reviewing Video Capture and Risk Data
timeFrame: 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at Shands Hospital
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Philip Efron, MD
role: PRINCIPAL_INVESTIGATOR
References: