Using a data capturing system to improve safety in endovascular procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study introduces an innovative 'Operating Room Black Box' designed to capture and analyze data during endovascular procedures. It aims to identify and prevent errors by assessing human and environmental factors, as well as measuring outcomes and events. The study will utilize data from a pilot project where the system was successfully implemented in a hybrid operating room. By analyzing the relationship between surgical leadership styles and team behavior, the research seeks to enhance patient safety and quality improvement in surgical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• UZ Gent
  Ghent, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Principal investigator: Isabelle Van Herzeele, MD, PhD — University Ghent
• Study coordinator: Isabelle Van Herzeele, MD, PhD
• Email: isabelle.vanherzeele@ugent.be
• Phone: 093325108

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.