Endovascular Procedures, Patient Safety, Quality Improvement
Conditions
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.
Interventions
OTHERMassive Open Online Course (MOOC)
Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists
Sponsors
University of Toronto
University Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| Technical Readiness and Acceptance | january 2023 until december 2025 | Team's technical readiness and acceptance towards a new technology (Lumiguide) in the hybrid operating room |
| Cognitive load | From January 1st 2023 until January 1st 2025 | Measured using the NASA-TLX |
| Radiation Safety - dose DAP | Through study completion, an average of 1.5 years | Assess radiation safety dose: Dose Area Product (DAP) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Team behavior | Through study completion, an average of 1.5 years | Assessment of team behavior indicators (speaking up, knowledge sharing, collaboration) via direct video coding |
| Leadership style | Through study completion, an average of 1.5 years | Assessment of leadership style according to the 'full range of leadership' theory via direct video coding |
Countries
Belgium
Contacts
Primary ContactIsabelle Van Herzeele, MD, PhD
Outcome results
None listed