Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
- Conditions
- Patient SafetyEndovascular ProceduresQuality Improvement
- Interventions
- Other: Massive Open Online Course (MOOC)
- Registration Number
- NCT04854278
- Lead Sponsor
- University Ghent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 222
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post measurement Massive Open Online Course (MOOC) Post measurement of +/- 100 cases after implementation of a Massive Open Online Course
- Primary Outcome Measures
Name Time Method Error Intraoperative errors will be measured per case through study completion, an average of 1.5 years. Evaluate errors during elective endovascular procedures in a hybrid room (error rate)
- Secondary Outcome Measures
Name Time Method Psycho-social well-being Through study completion, an average of 1.5 years Assess psycho-social well-being of teammembers in the hybrid room via a pre and post procedure survey for each case
Technical skills - EVAR - EVARATE Through study completion, an average of 1.5 years Assess technical skills of the surgeon on EVARATE (EndoVascular Aortic Repair Assessment of Technical Expertise) (range: 7-35) (the higher the score, the better)
Distractions - doors Through study completion, an average of 1.5 years Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number of times doors open
Radiation Safety - behavior Through study completion, an average of 1.5 years Assess radiation safety behavior: Radiation safety scale (Range: 11-55) (the higher the score, the better)
Non-technical skills - surgical team Through study completion, an average of 1.5 years Assess non-technical skills of the surgeon via NOTSS (Non-Technical Skills for Surgeons)
Distractions - people Through study completion, an average of 1.5 years Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Maximal number of people in the room
Radiation Safety - dose AK Through study completion, an average of 1.5 years Assess radiation safety dose: Air Kerma (AK)
Radiation Safety - fluoroscopy time Through study completion, an average of 1.5 years Assess radiation safety dose: Fluoroscopy time (FT)
Technical skills - PVI Through study completion, an average of 1.5 years Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better)
Technical skills - EVAR - GRS Through study completion, an average of 1.5 years Assess technical skills of the surgeon on Global rating scale (GRS) (range: 8-40) (the higher the score, the better)
Technical skills - EVAR - PRS Through study completion, an average of 1.5 years Assess technical skills of the surgeon on Procedure Specific rating scale (PRS) (range: 7-35) (the higher the score, the better)
Non-technical skills - nursing team Through study completion, an average of 1.5 years Assess non-technical skills of the surgeon via SPLINTS (Non-technical skills of the scrub practitioner)
Distractions - auditory Through study completion, an average of 1.5 years Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number and type of Auditory distractions
Radiation Safety - dose DAP Through study completion, an average of 1.5 years Assess radiation safety dose: Dose Area Product (DAP)
Incident reports Through study completion, an average of 1.5 years Assess number of incident reports (obligatory existing platform in the hospital to report incidents) during Operation Black Black Box (ORBB) cases - incident rate
Error work culture Through study completion, an average of 1.5 years Assess error work culture in the hybrid room via a baseline survey: 10 items, each scored on a 5-Point Likert scale
Trial Locations
- Locations (1)
UZ Gent
🇧🇪Ghent, Oost-Vlaanderen, Belgium