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

NCT04854278 | Recruiting

• 1 other identifier: BC-02220
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality Improvement; Patient Safety; Endovascular Procedures

Outcome Measures

Primary Outcomes (1)

• Error

  Evaluate errors during elective endovascular procedures in a hybrid room (error rate)

  Intraoperative errors will be measured per case through study completion, an average of 1.5 years.

Secondary Outcomes (18)

• Technical skills - PVI

  Through study completion, an average of 1.5 years

• Technical skills - EVAR - GRS

  Through study completion, an average of 1.5 years

• Technical skills - EVAR - PRS

  Through study completion, an average of 1.5 years

• Technical skills - EVAR - EVARATE

  Through study completion, an average of 1.5 years

• Non-technical skills - surgical team

  Through study completion, an average of 1.5 years

Other Outcomes (2)

• Team behavior

  Through study completion, an average of 1.5 years

• Leadership style

  Through study completion, an average of 1.5 years

Study Arms (4)

Pilot study

Pilot study with 22 cases, no intervention

Baseline measurement

Baseline measurement of +/- 100 cases, no intervention

Post measurement

Post measurement of +/- 100 cases after implementation of a Massive Open Online Course

Other: Massive Open Online Course (MOOC)

Registry of endovascular cases

Starting 1 january 2023

Interventions

Massive Open Online Course (MOOC) OTHER

Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists

Also known as: Radiation Safety in the hybrid room: the do's and don'ts

Post measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planned for endovascular intervention at Ghent University Hospital.

You may qualify if:

• Patients undergoing elective (planned more than 48 hours) endovascular procedures.
• Symptomatic aortic-iliac-femoral-popliteal-below the knee atherosclerotic stenotic or occlusive disease (PVI)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• University of Toronto: collaborator

Study Sites (1)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Related Publications (9)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 36168949 RESULT

Study Officials

• Isabelle Van Herzeele, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Van Herzeele, MD, PhD

CONTACT

093325108; isabelle.vanherzeele@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 22, 2021
• Study Start: February 19, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)