Actively Recruiting

Age: 18Years +
All Genders
ID04854278

Development of Strategies to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room - an Inter-professional Approach to Enhance Technical and Non-technical Performance and to Improve Patient Safety

Led by University Ghent · Updated on 2025-12-22

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Ghent

Lead Sponsor

U

University of Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective endovascular procedures planned more than 48 hours in advance
  • Diagnosis of symptomatic atherosclerotic disease affecting aortic, iliac, femoral, popliteal, or below the knee arteries (PVI)
  • Scheduled for endovascular exclusion of thoracic aortic, infrarenal abdominal aortic, and/or iliac aneurysm repair (EVAR)
Not Eligible

You will not qualify if you...

  • Lack of patient consent
  • Lack of consent from all endovascular team members
  • Emergency procedures planned less than 48 hours before
  • Endovascular procedures not treating specified atherosclerotic or aneurysm diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

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

Trial Site Locations

Total: 1 location

1

UZ Gent

Ghent, Oost-Vlaanderen, Belgium, 9000

Actively Recruiting

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Research Team

I

Isabelle Van Herzeele, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Development, Feasibility, and Knowledge Impact of a Massive Open Online Course on Radiation Safety: A Multicentre Prospective Cohort Study.

Gilles Soenens, Bart Doyen, Peter Vlerick...

https://pubmed.ncbi.nlm.nih.gov/38042252

Editor's Choice - Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions.

Gilles Soenens, Lauren Gorden, Bart Doyen...

https://pubmed.ncbi.nlm.nih.gov/38492630

Assessment of Endovascular Team Performances Using a Comprehensive Data Capture Platform in the Hybrid Room: A Pilot Study.

Gilles Soenens, Bart Doyen, Peter Vlerick...

https://pubmed.ncbi.nlm.nih.gov/33744093