Patient SafetyNCT04854278
Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
An observational study of Patient Safety and Endovascular Procedures, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety, Endovascular Procedures, Quality Improvement
- What is being tested?
- Massive Open Online Course (MOOC)
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Feb 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for endovascular intervention at Ghent University Hospital.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Gent
Ghent, Oost-Vlaanderen, 9000
Isabelle Van Herzeele, MD, PhD, 093325108 ext. +32, isabelle.vanherzeele@ugent.be
About this study
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
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.
Read more
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
- Patient Safety, Endovascular Procedures, Quality Improvement
- Being tested
- Massive Open Online Course (MOOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massive Open Online Course (MOOC)Other
Also called Radiation Safety in the hybrid room: the do's and don'ts
Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Massive Open Online Course (MOOC) | |
| Registry of endovascular cases | Starting 1 january 2023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error
Evaluate errors during elective endovascular procedures in a hybrid room (error rate)
Measured: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.
Secondary outcomes (18)
Technical skills - PVI
Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better)
Measured: Through study completion, an average of 1.5 years
Technical skills - EVAR - GRS
Assess technical skills of the surgeon on Global rating scale (GRS) (range: 8-40) (the higher the score, the better)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 1.5 years
Radiation Safety - dose DAP
Assess radiation safety dose: Dose Area Product (DAP)
Measured: Through study completion, an average of 1.5 years
Radiation Safety - dose AK
Assess radiation safety dose: Air Kerma (AK)
Measured: Through study completion, an average of 1.5 years
Radiation Safety - fluoroscopy time
Assess radiation safety dose: Fluoroscopy time (FT)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: january 2023 until december 2025
Cognitive load
Measured using the NASA-TLX
Measured: From January 1st 2023 until January 1st 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start19 Feb 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Isabelle Van Herzeele, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854278
- Sponsor's protocol ID
- BC-02220
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35012393Soenens 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.
PubMed 35904023Soenens 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.
PubMed 38042252Soenens 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.
PubMed 38492630Soenens 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.
PubMed 40633718Kaya 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.
PubMed 40302105Soenens 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.
PubMed 33744093Doyen 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.
PubMed 32615511Doyen 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.
PubMed 36168949
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04854278
- Acronym / sponsor ID
- BC-02220
- Conditions
- Patient Safety, Endovascular Procedures, Quality Improvement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pilot study | – | –Pilot study with 22 cases, no intervention |
| Baseline measurement | – | –Baseline measurement of +/- 100 cases, no intervention |
| Post measurement | – | Other: Massive Open Online Course (MOOC)Post measurement of +/- 100 cases after implementation of a Massive Open Online Course |
| Registry of endovascular cases | – | –Starting 1 january 2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for endovascular intervention at Ghent University Hospital.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massive Open Online Course (MOOC)Also: Radiation Safety in the hybrid room: the do's and don'tsCombination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists | Other | Post measurement |
Primary outcome
Error
Time frame: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.
Evaluate errors during elective endovascular procedures in a hybrid room (error rate)
18 secondary outcomes
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
Radiation Safety - behavior
Time frame: Through study completion, an average of 1.5 years
Error work culture
Time frame: Through study completion, an average of 1.5 years
Psycho-social well-being
Time frame: Through study completion, an average of 1.5 years
Incident reports
Time frame: Through study completion, an average of 1.5 years
Technical Readiness and Acceptance
Time frame: january 2023 until december 2025
Cognitive load
Time frame: From January 1st 2023 until January 1st 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 35012393Gordon 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.
- Results publication: PubMed 35904023Soenens 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.
- Results publication: PubMed 38042252Soenens 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.
- Results publication: PubMed 38492630Soenens 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.
- Results publication: PubMed 40633718Soenens 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.
- Results publication: PubMed 40302105Kaya 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.
- Results publication: PubMed 33744093Soenens 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.
- Results publication: PubMed 32615511Doyen 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.
- Results publication: PubMed 36168949Doyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Van Herzeele, MD, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety and Endovascular Procedures, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Van Herzeele, MD, PhD (093325108 ext. +32, isabelle.vanherzeele@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error (time frame: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854278, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.