- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400172
AI-Generated Video Feedback to Improve Technical Skills in Coronary Artery Bypass Grafting
Study Overview
Status
Intervention / Treatment
Detailed Description
Coronary artery bypass grafting (CABG) is a complex surgical procedure that requires a high level of technical skill from cardiac surgeons. Variability in surgical technique may influence procedural quality and patient outcomes. Recent advances in artificial intelligence (AI) have enabled automated assessment of surgical performance using operative video data, creating new opportunities for objective feedback and surgical education.
This study aims to evaluate whether targeted video feedback generated by an AI-based surgical performance assessment model can help cardiac surgeons improve their technical skills in CABG procedures. Participating surgeons whose baseline technical performance ranked in the lower half of the AI scoring system will receive personalized video feedback highlighting operative steps and maneuvers associated with lower performance scores.
In this single-group, self-controlled study, each participating surgeon will submit a baseline CABG surgical video, which will be independently evaluated by both the AI model and a panel of experienced cardiac surgeons using standardized scoring criteria. After receiving AI-generated video feedback, surgeons will be given one month to review and reflect on the feedback without additional formal training or coaching. A follow-up CABG surgical video will then be submitted and assessed using the same evaluation process.
The primary outcome of the study is the change in technical skill scores assigned by human expert raters between the baseline and follow-up videos. Secondary outcomes include surgeons' self-assessments of AI-identified performance deficits, agreement between AI-generated feedback and human expert feedback, and selected patient postoperative in-hospital outcomes. The findings of this study may inform the role of AI-assisted video feedback as a scalable educational tool for surgical skill development.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lihua Zhang Zhang, M.D, Ph.D
- Phone Number: 13810483387
- Email: zhanghaibo@fuwai.com
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 102300
- Fuwai Hospital
-
Contact:
- Lihua Zhang Zhang, M.D, Ph.D
- Phone Number: 15920826832
- Email: leilubi@fuwai.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Baseline AI-assessed technical performance ranked in the lower 50% within the scoring system in CAMERA study (NCT06739005)
Exclusion Criteria:
- Unwilling to attend
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 |
|---|---|
|
Experimental: AI-Guided Video Feedback Intervention
Participants in this study will receive a personalized educational intervention consisting of AI-generated video feedback based on their baseline coronary artery bypass grafting (CABG) surgical videos.
The AI model analyzes surgical performance and identifies specific operative steps with lower technical skill scores.
Curated video clips highlighting these areas are provided to the surgeons for self-review and reflection.
No additional formal training or coaching is given during the one-month intervention period, after which a follow-up surgical video is submitted for re-evaluation.
|
Participants in this study will receive a personalized educational intervention consisting of AI-generated video feedback based on their baseline coronary artery bypass grafting (CABG) surgical videos.
The AI model analyzes surgical performance and identifies specific operative steps with lower technical skill scores.
Curated video clips highlighting these areas are provided to the surgeons for self-review and reflection.
No additional formal training or coaching is given during the one-month intervention period, after which a follow-up surgical video is submitted for re-evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Human Expert-Rated Technical Skill Score Between Baseline and Follow-Up CABG Videos
Time Frame: Baseline, 1 month
|
The primary outcome is the change in technical skill scores assigned by a panel of blinded human expert raters, who independently evaluate anonymized coronary artery bypass grafting (CABG) surgical videos submitted at baseline and one month after receiving AI-generated video feedback.
The scoring uses a standardized rubric to assess overall surgical technical performance.
The higher score, the better performance: respect for tissue, time and motion, instrument handling, knowledge of instruments, use of assistants, flow of operation and forward planning, and knowledge of the specific procedure.
Each domain was scored on a 5-point Likert scale, where 1 indicated poor performance and 5 represented excellence.
In addition, each rater provided an overall impression score (1-5) to capture their holistic assessment of surgical performance.
The two scores were scaled to 100 points and the final score consists of 70% of 7-domain rating sum scores and 30% of overall impression score.
|
Baseline, 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgeon self-assessments of the AI feedback
Time Frame: 1 month
|
Surgeons will review the AI-generated video clips highlighting technical performance deficits and complete a self-assessment questionnaire evaluating their satisfaction of the AI feedback.
|
1 month
|
|
Consistency between AI feedback and human expert feedback.
Time Frame: Baseline, 1 month
|
This outcome assesses the consistency between the AI-generated surgical performance feedback and evaluations provided by human expert raters.
AI-score was generated by a two-stage deep learning framework and human expert raters' score was generated by a validated 7-domain rating scale as detailed in the primary outcome.
The intraclass correlation coefficient (ICC) will be used to assess the consistency between the surgical technique scores assessed by the AI model and those rated by human expert raters.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the icidence of major complications
Time Frame: Baseline, 1 month
|
Patient postoperative in-hospital outcomes will be collected and analyzed to explore any associations with changes in surgeon technical performance following the AI feedback intervention.
The incidence of major complications (a composite outcome of death, acute kidney injury, myocardial infarction and stroke)
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of death
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of death.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of acute kidney injury
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of acute kidney injury.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of myocardial infarction
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of myocardial infarction.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of stroke
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of stroke.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of secondary thoracotomy
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of secondary thoracotomy.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of IABP implantation
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of IABP implantation.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of ECMO implantation
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of ECMO implantation.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of bedside hemofiltration
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of bedside hemofiltration.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of peritoneal dialysis
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of peritoneal dialysis.
|
Baseline, 1 month
|
|
Postoperative in-hospital outcomes: the incidence of tracheotomy
Time Frame: Baseline, 1 month
|
The associations with changes in surgeon technical performance following the AI feedback intervention and the incidence of tracheotomy.
|
Baseline, 1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Other Study ID Numbers
- FW-HSS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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