Using a data capturing system to improve safety in endovascular procedures
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
University Ghent · NCT04854278
This study is testing a new system that records data during endovascular surgeries to see if it can help prevent mistakes and improve patient safety.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Ghent (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT04854278 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing elective endovascular procedures for atherosclerotic disease or aneurysm repair.
Not a fit: Patients undergoing emergency procedures or those who do not consent to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient safety and reduce errors in endovascular procedures.
How similar studies have performed: Other studies utilizing similar data capturing systems in surgical settings have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ghent, Oost-Vlaanderen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patient Safety, Endovascular Procedures, Quality Improvement