An observational study in Patient Safety, Endovascular Procedures and Quality Improvement, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by University Ghent · Observational
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.
University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients planned for endovascular intervention at Ghent University Hospital.
Exclusion Criteria:
Pilot study with 22 cases, no intervention
Baseline measurement of +/- 100 cases, no intervention
Post measurement of +/- 100 cases after implementation of a Massive Open Online Course
Other: Massive Open Online Course (MOOC)
Starting 1 january 2023
Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists
Also known as: Radiation Safety in the hybrid room: the do's and don'ts
Error
Evaluate errors during elective endovascular procedures in a hybrid room (error rate)
Time frame: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.
Technical skills - PVI
Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1.5 years
Radiation Safety - dose DAP
Assess radiation safety dose: Dose Area Product (DAP)
Time frame: Through study completion, an average of 1.5 years
Radiation Safety - dose AK
Assess radiation safety dose: Air Kerma (AK)
Time frame: Through study completion, an average of 1.5 years
Radiation Safety - fluoroscopy time
Assess radiation safety dose: Fluoroscopy time (FT)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1.5 years
Technical Readiness and Acceptance
Team's technical readiness and acceptance towards a new technology (Lumiguide) in the hybrid operating room
Time frame: january 2023 until december 2025
Cognitive load
Measured using the NASA-TLX
Time frame: From January 1st 2023 until January 1st 2025
Team behavior
Assessment of team behavior indicators (speaking up, knowledge sharing, collaboration) via direct video coding
Time frame: Through study completion, an average of 1.5 years
Leadership style
Assessment of leadership style according to the 'full range of leadership' theory via direct video coding
Time frame: Through study completion, an average of 1.5 years
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Ghent