Step, Error, and Event Frameworks in Endovascular Aortic Repair.
Lauren Gordon, Gilles Soenens, Bart Doyen...
https://pubmed.ncbi.nlm.nih.gov/35012393Actively Recruiting
Led by University Ghent · Updated on 2025-12-22
400
Participants Needed
1
Research Sites
N/A
Total Duration
U
University Ghent
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
Researchers are investigating patient safety and quality improvement during endovascular procedures by using a novel "OR Black box" system. This multiport data capturing technology records detailed information on surgeries, including technical and non-technical factors such as teamwork, leadership, environmental influences, and error rates. The study aims to understand how these factors relate to surgical performance and to identify chains of errors and high-risk events for better safety strategies. The study includes several phases: a pilot study with 22 cases, a baseline measurement of around 100 cases without intervention, and a post-measurement phase of approximately 100 cases after introducing a Massive Open Online Course (MOOC) for the endovascular team. The MOOC combines knowledge training with video scenarios and game-based learning for surgeons, nurses, and anesthetists. Data collection started in February 2019 and includes a registry of endovascular cases. Participants will be observed during elective endovascular procedures treating specific vascular diseases. Researchers will monitor intraoperative errors, technical skills, non-technical skills, distractions, radiation safety, team culture, and psycho-social well-being over about 1.5 years. Assessments include direct video coding, incident reports, and cognitive load evaluations. The goal is to improve surgical outcomes by analyzing performance and safety factors in the hybrid operating room environment.
CONDITIONS
Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1.5 years
Participants are observed during elective endovascular procedures to identify and analyze intraoperative errors and technical and non-technical performance.
Observations during approximately 100 baseline cases and 100 post-course cases
Total: 1 location
1
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
I
Isabelle Van Herzeele, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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