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Clinical Trials in Belgium / NCT04854278
Recruiting Observational

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

NCT04854278 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2019-02-19
Last updated
2025-12-22

Condition(s) studied

Patient SafetyEndovascular ProceduresQuality Improvement

Investigational drug(s) / intervention(s)

Massive Open Online Course (MOOC)

Massive Open Online Course (MOOC): Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
UZ Gent Ghent Oost-Vlaanderen Recruiting

More University Ghent trials in Belgium

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04854278 on ClinicalTrials.gov ↗ ← All trials in Belgium