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

December 15, 2025 updated by: University Ghent

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients planned for endovascular intervention at Ghent University Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists
Other Names:
  • Radiation Safety in the hybrid room: the do's and don'ts
Registry of endovascular cases
Starting 1 january 2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Intraoperative errors will be measured per case through study completion, an average of 1.5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical skills - PVI
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
Assess radiation safety dose: Dose Area Product (DAP)
Through study completion, an average of 1.5 years
Radiation Safety - dose AK
Time Frame: Through study completion, an average of 1.5 years
Assess radiation safety dose: Air Kerma (AK)
Through study completion, an average of 1.5 years
Radiation Safety - fluoroscopy time
Time Frame: Through study completion, an average of 1.5 years
Assess radiation safety dose: Fluoroscopy time (FT)
Through study completion, an average of 1.5 years
Radiation Safety - behavior
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: january 2023 until december 2025
Team's technical readiness and acceptance towards a new technology (Lumiguide) in the hybrid operating room
january 2023 until december 2025
Cognitive load
Time Frame: From January 1st 2023 until January 1st 2025
Measured using the NASA-TLX
From January 1st 2023 until January 1st 2025

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Team behavior
Time Frame: Through study completion, an average of 1.5 years
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
Time Frame: Through study completion, an average of 1.5 years
Assessment of leadership style according to the 'full range of leadership' theory via direct video coding
Through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Isabelle Van Herzeele, MD, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 2, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • BC-02220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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