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NCT Number: NCT04854278

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

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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Key information

Conditions

Patient Safety Endovascular Procedures Quality Improvement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location status: Recruiting

Location contact

Isabelle Van Herzeele, MD, PhD

CONTACT

[email protected]

093325108 ext. +32

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Radiation Safety in the hybrid room: the do's and don'ts

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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

  8. 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

  9. 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

  10. Radiation Safety - dose DAP

    Time frame: Through study completion, an average of 1.5 years

    Assess radiation safety dose: Dose Area Product (DAP)

  11. Radiation Safety - dose AK

    Time frame: Through study completion, an average of 1.5 years

    Assess radiation safety dose: Air Kerma (AK)

  12. Radiation Safety - fluoroscopy time

    Time frame: Through study completion, an average of 1.5 years

    Assess radiation safety dose: Fluoroscopy time (FT)

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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

  18. Cognitive load

    Time frame: From January 1st 2023 until January 1st 2025

    Measured using the NASA-TLX

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Van Herzeele, MD, PhD

CONTACT

[email protected]

093325108 ext. +32

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • University of Toronto

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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