Clinical trial NCT04854278: Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Safety
Endovascular Procedures
Quality Improvement
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2021-04-22
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for endovascular intervention at Ghent University Hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Error
timeFrame: Intraoperative errors will be measured per case through study completion, an average of 1.5 years.
Secondary outcomes:
measure: Technical skills - PVI
timeFrame: Through study completion, an average of 1.5 years
measure: Technical skills - EVAR - GRS
timeFrame: Through study completion, an average of 1.5 years
measure: Technical skills - EVAR - PRS
timeFrame: Through study completion, an average of 1.5 years
measure: Technical skills - EVAR - EVARATE
timeFrame: Through study completion, an average of 1.5 years
measure: Non-technical skills - surgical team
timeFrame: Through study completion, an average of 1.5 years
measure: Non-technical skills - nursing team
timeFrame: Through study completion, an average of 1.5 years
measure: Distractions - auditory
timeFrame: Through study completion, an average of 1.5 years
measure: Distractions - people
timeFrame: Through study completion, an average of 1.5 years
measure: Distractions - doors
timeFrame: Through study completion, an average of 1.5 years
measure: Radiation Safety - dose DAP
timeFrame: Through study completion, an average of 1.5 years
measure: Radiation Safety - dose AK
timeFrame: Through study completion, an average of 1.5 years
measure: Radiation Safety - fluoroscopy time
timeFrame: Through study completion, an average of 1.5 years
measure: Radiation Safety - behavior
timeFrame: Through study completion, an average of 1.5 years
measure: Error work culture
timeFrame: Through study completion, an average of 1.5 years
measure: Psycho-social well-being
timeFrame: Through study completion, an average of 1.5 years
measure: Incident reports
timeFrame: Through study completion, an average of 1.5 years
Other outcomes:
measure: Team behavior
timeFrame: Through study completion, an average of 1.5 years
measure: Leadership style
timeFrame: Through study completion, an average of 1.5 years
Locations:
city: Ghent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Isabelle Van Herzeele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.