Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

Study Overview
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Brief Summary
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The OR Black box, an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures. Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery. This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level. Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.

Official Title
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Development of Strategies to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room - an Inter-professional Approach to Enhance Technical and Non-technical Performance and to Improve Patient Safety

Conditions
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Patient Safety, Endovascular Procedures, Quality Improvement

Intervention / Treatment
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* Other: Massive Open Online Course (MOOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective (planned more than 48 hours) endovascular procedures. Symptomatic aortic-iliac-femoral-popliteal-below the knee atherosclerotic stenotic or occlusive disease (PVI) Endovascular exclusion of thoracic aortic, infrarenal abdominal aortic and/or iliac aneurysm repair (EVAR) Exclusion Criteria: No consent of patient No consent of all endovascular team members Emergency procedure (planned < 48h before) Endovascular procedure not treating atherosclerotic aortic-iliac-femoral-popliteal-below the knee disease or aortic-iliac aneurysm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot study<br>Pilot study with 22 cases, no intervention | |
| Baseline measurement<br>Baseline measurement of +/- 100 cases, no intervention | |
| Post measurement<br>Post measurement of +/- 100 cases after implementation of a Massive Open Online Course | Other: Massive Open Online Course (MOOC)<br>* Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists<br>* Other names: Radiation Safety in the hybrid room: the do's and don'ts;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Error | Evaluate errors during elective endovascular procedures in a hybrid room (error rate) | Intraoperative errors will be measured per case through study completion, an average of 1.5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical skills - PVI | Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better) | Through study completion, an average of 1.5 years | 
| Technical skills - EVAR - GRS | Assess technical skills of the surgeon on Global rating scale (GRS) (range: 8-40) (the higher the score, the better) | Through study completion, an average of 1.5 years | 
| Technical skills - EVAR - PRS | Assess technical skills of the surgeon on Procedure Specific rating scale (PRS) (range: 7-35) (the higher the score, the better) | Through study completion, an average of 1.5 years | 
| Technical skills - EVAR - EVARATE | Assess technical skills of the surgeon on EVARATE (EndoVascular Aortic Repair Assessment of Technical Expertise) (range: 7-35) (the higher the score, the better) | Through study completion, an average of 1.5 years | 
| Non-technical skills - surgical team | Assess non-technical skills of the surgeon via NOTSS (Non-Technical Skills for Surgeons) | Through study completion, an average of 1.5 years | 
| Non-technical skills - nursing team | Assess non-technical skills of the surgeon via SPLINTS (Non-technical skills of the scrub practitioner) | Through study completion, an average of 1.5 years | 
| Distractions - auditory | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number and type of Auditory distractions | Through study completion, an average of 1.5 years | 
| Distractions - people | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Maximal number of people in the room | Through study completion, an average of 1.5 years | 
| Distractions - doors | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number of times doors open | Through study completion, an average of 1.5 years | 
| Radiation Safety - dose DAP | Assess radiation safety dose: Dose Area Product (DAP) | Through study completion, an average of 1.5 years | 
| Radiation Safety - dose AK | Assess radiation safety dose: Air Kerma (AK) | Through study completion, an average of 1.5 years | 
| Radiation Safety - fluoroscopy time | Assess radiation safety dose: Fluoroscopy time (FT) | Through study completion, an average of 1.5 years | 
| Radiation Safety - behavior | Assess radiation safety behavior: Radiation safety scale (Range: 11-55) (the higher the score, the better) | Through study completion, an average of 1.5 years | 
| Error work culture | Assess error work culture in the hybrid room via a baseline survey: 10 items, each scored on a 5-Point Likert scale | Through study completion, an average of 1.5 years | 
| Psycho-social well-being | Assess psycho-social well-being of teammembers in the hybrid room via a pre and post procedure survey for each case | Through study completion, an average of 1.5 years | 
| Incident reports | Assess number of incident reports (obligatory existing platform in the hospital to report incidents) during Operation Black Black Box (ORBB) cases - incident rate | Through study completion, an average of 1.5 years |