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| Name | Class |
|---|---|
| University of Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Registry of endovascular cases | Starting 1 january 2023 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical skills - PVI | Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better) | Through study completion, an average of 1.5 years |
| Technical skills - EVAR - GRS |
| Measure | Description | Time Frame |
|---|---|---|
| Team behavior | Assessment of team behavior indicators (speaking up, knowledge sharing, collaboration) via direct video coding | Through study completion, an average of 1.5 years |
| Leadership style | Assessment of leadership style according to the 'full range of leadership' theory via direct video coding |
Inclusion Criteria:
Exclusion Criteria:
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Patients planned for endovascular intervention at Ghent University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Van Herzeele, MD, PhD | Contact | 093325108 | +32 | isabelle.vanherzeele@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Van Herzeele, MD, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35012393 | Result | 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. | |
| 35904023 | 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. |
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Assess technical skills of the surgeon on Global rating scale (GRS) (range: 8-40) (the higher the score, the better)
| Through study completion, an average of 1.5 years |
| Technical skills - EVAR - PRS | Assess technical skills of the surgeon on Procedure Specific rating scale (PRS) (range: 7-35) (the higher the score, the better) | Through study completion, an average of 1.5 years |
| Technical skills - EVAR - EVARATE | Assess technical skills of the surgeon on EVARATE (EndoVascular Aortic Repair Assessment of Technical Expertise) (range: 7-35) (the higher the score, the better) | Through study completion, an average of 1.5 years |
| Non-technical skills - surgical team | Assess non-technical skills of the surgeon via NOTSS (Non-Technical Skills for Surgeons) | Through study completion, an average of 1.5 years |
| Non-technical skills - nursing team | Assess non-technical skills of the surgeon via SPLINTS (Non-technical skills of the scrub practitioner) | Through study completion, an average of 1.5 years |
| Distractions - auditory | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number and type of Auditory distractions | Through study completion, an average of 1.5 years |
| Distractions - people | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Maximal number of people in the room | Through study completion, an average of 1.5 years |
| Distractions - doors | Assess distractions in the hybrid room: DiSI (Distractions in surgery index). Number of times doors open | Through study completion, an average of 1.5 years |
| Radiation Safety - dose DAP | Assess radiation safety dose: Dose Area Product (DAP) | Through study completion, an average of 1.5 years |
| Radiation Safety - dose AK | Assess radiation safety dose: Air Kerma (AK) | Through study completion, an average of 1.5 years |
| Radiation Safety - fluoroscopy time | Assess radiation safety dose: Fluoroscopy time (FT) | Through study completion, an average of 1.5 years |
| Radiation Safety - behavior | Assess radiation safety behavior: Radiation safety scale (Range: 11-55) (the higher the score, the better) | Through study completion, an average of 1.5 years |
| Error work culture | Assess error work culture in the hybrid room via a baseline survey: 10 items, each scored on a 5-Point Likert scale | Through study completion, an average of 1.5 years |
| Psycho-social well-being | Assess psycho-social well-being of teammembers in the hybrid room via a pre and post procedure survey for each case | Through study completion, an average of 1.5 years |
| Incident reports | Assess number of incident reports (obligatory existing platform in the hospital to report incidents) during Operation Black Black Box (ORBB) cases - incident rate | Through study completion, an average of 1.5 years |
| Technical Readiness and Acceptance | Team's technical readiness and acceptance towards a new technology (Lumiguide) in the hybrid operating room | january 2023 until december 2025 |
| Cognitive load | Measured using the NASA-TLX | From January 1st 2023 until January 1st 2025 |
| Through study completion, an average of 1.5 years |
| 38042252 | 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. |
| 38492630 | 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. |
| 40633718 | 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. |
| 40302105 | 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. |
| 33744093 | 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. |
| 32615511 | 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. |
| 36168949 | 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. |