Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576570
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation and Modification of Surgeon Ergonomics in the Operation Room Using Artificial Intelligence Analytics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None