Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
NCT ID: NCT04854278
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2019-02-19
2027-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pilot study
Pilot study with 22 cases, no intervention
No interventions assigned to this group
Baseline measurement
Baseline measurement of +/- 100 cases, no intervention
No interventions assigned to this group
Post measurement
Post measurement of +/- 100 cases after implementation of a Massive Open Online Course
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
Registry of endovascular cases
Starting 1 january 2023
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University of Toronto
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Isabelle Van Herzeele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Countries
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Central Contacts
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Facility Contacts
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Isabelle Van Herzeele, MD, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Doyen B, Soenens G, Maurel B, Hertault A, Gordon L, Vlerick P, Vermassen F, Grantcharov T, van Herzeele I. Assessing endovascular team performances in a hybrid room using the Black Box system: a prospective cohort study. J Cardiovasc Surg (Torino). 2023 Feb;64(1):82-92. doi: 10.23736/S0021-9509.22.12226-3. Epub 2022 Sep 28.
Other Identifiers
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BC-02220
Identifier Type: -
Identifier Source: org_study_id