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Recruiting NCT04854278

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

— Observational Patient Safety Endovascular Procedures Quality Improvement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Massive Open Online Course (MOOC).
Who it may be relevant to
Registry conditions: Patient Safety, Endovascular Procedures, Quality Improvement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures. Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery. This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level. Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.

Interventions

  • Other Massive Open Online Course (MOOC)
    Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists

Primary outcome measures

  • Error [Time frame: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.]
Secondary outcome measures (12)
  • Technical skills - PVI [Time frame: Through study completion, an average of 1.5 years]
  • Technical skills - EVAR - GRS [Time frame: Through study completion, an average of 1.5 years]
  • Technical skills - EVAR - PRS [Time frame: Through study completion, an average of 1.5 years]
  • Technical skills - EVAR - EVARATE [Time frame: Through study completion, an average of 1.5 years]
  • Non-technical skills - surgical team [Time frame: Through study completion, an average of 1.5 years]
  • Non-technical skills - nursing team [Time frame: Through study completion, an average of 1.5 years]
  • Distractions - auditory [Time frame: Through study completion, an average of 1.5 years]
  • Distractions - people [Time frame: Through study completion, an average of 1.5 years]
  • Distractions - doors [Time frame: Through study completion, an average of 1.5 years]
  • Radiation Safety - dose DAP [Time frame: Through study completion, an average of 1.5 years]
  • Radiation Safety - dose AK [Time frame: Through study completion, an average of 1.5 years]
  • Radiation Safety - fluoroscopy time [Time frame: Through study completion, an average of 1.5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Gent — Ghent

Publications

  • Gordon L, Soenens G, Doyen B, Sunavsky J, Wheatcroft M, de Mestral C, Palter V, Grantcharov T, Van Herzeele I. Step, Error, and Event Frameworks in Endovascular Aortic Repair. J Endovasc Ther. 2022 Dec;29(6):937-947. doi: 10.1177/15266028211068768. Epub 2022 Jan 11. PMID 35012393
  • Soenens G, Marchand B, Doyen B, Grantcharov T, Van Herzeele I, Vlerick P. Surgeons' Leadership Style and Team Behavior in the Hybrid Operating Room: Prospective Cohort Study. Ann Surg. 2023 Jul 1;278(1):e5-e12. doi: 10.1097/SLA.0000000000005645. Epub 2022 Jul 29. PMID 35904023
  • Soenens G, Doyen B, Vlerick P, Hertault A, Maurel B, Kellens PJ, Bacher K, Van Herzeele I; VESTA (Vascular surgery in Europe radiation SafeTy Alliance). Development, Feasibility, and Knowledge Impact of a Massive Open Online Course on Radiation Safety: A Multicentre Prospective Cohort Study. Eur J Vasc Endovasc Surg. 2024 May;67(5):838-846. doi: 10.1016/j.ejvs.2023.11.047. Epub 2023 Dec 1. PMID 38042252
  • Soenens G, Gorden L, Doyen B, Wheatcroft M, de Mestral C, Palter V, Van Herzeele I; ENDORATE-PVI consortium. Editor's Choice - Development and Testing of Step, Error, and Event Frameworks to Evaluate Technical Performance in Peripheral Endovascular Interventions. Eur J Vasc Endovasc Surg. 2024 Aug;68(2):227-235. doi: 10.1016/j.ejvs.2024.03.007. Epub 2024 Mar 15. PMID 38492630
  • Soenens G, Vlerick P, Bacher K, Rennie N, Grantcharov T, Van Herzeele I. Impact of a Massive Open Online Course on Radiation Safety in the Hybrid Operating Room. Eur J Vasc Endovasc Surg. 2025 Nov;70(5):693-694. doi: 10.1016/j.ejvs.2025.07.002. Epub 2025 Jul 7. No abstract available. PMID 40633718
  • Kaya J, Bonte E, Rennie N, Soenens G, Moreels N, Vlerick P, Van Herzeele I. Mapping Distractions in the Hybrid Operating Room During Elective Endovascular Aortic Procedures. World J Surg. 2025 Jun;49(6):1676-1682. doi: 10.1002/wjs.12605. Epub 2025 Apr 29. PMID 40302105
  • Soenens G, Doyen B, Vlerick P, Vermassen F, Grantcharov T, Van Herzeele I. Assessment of Endovascular Team Performances Using a Comprehensive Data Capture Platform in the Hybrid Room: A Pilot Study. Eur J Vasc Endovasc Surg. 2021 Jun;61(6):1028-1029. doi: 10.1016/j.ejvs.2021.02.021. Epub 2021 Mar 17. No abstract available. PMID 33744093
  • Doyen B, Gordon L, Soenens G, Bacher K, Vlerick P, Vermassen F, Grantcharov T, Van Herzeele I. Introduction of a surgical Black Box system in a hybrid angiosuite: Challenges and opportunities. Phys Med. 2020 Aug;76:77-84. doi: 10.1016/j.ejmp.2020.06.013. Epub 2020 Jun 29. PMID 32615511

Identifiers

NCT: NCT04854278 · BC-02220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗