Status:
RECRUITING
Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
Lead Sponsor:
University Ghent
Collaborating Sponsors:
University of Toronto
Conditions:
Patient Safety
Endovascular Procedures
Eligibility:
All Genders
18+ years
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04854278
Start Date
February 19 2019
End Date
December 31 2027
Last Update
December 22 2025
Active Locations (1)
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1
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000