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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854278
• Other study ID #: BC-02220
• Status: Recruiting
• Start date: February 19, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: University Ghent
• Contact: Isabelle Van Herzeele, MD, PhD
• Phone: 093325108
• Email: isabelle.vanherzeele[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 222
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Procedures
• Patient Safety
• Quality Improvement

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Gent	Ghent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University of Toronto

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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 F — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Leadership style	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
Primary	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.
Secondary	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
Secondary	Technical skills - EVAR - GRS	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Radiation Safety - dose DAP	Assess radiation safety dose: Dose Area Product (DAP)	Through study completion, an average of 1.5 years
Secondary	Radiation Safety - dose AK	Assess radiation safety dose: Air Kerma (AK)	Through study completion, an average of 1.5 years
Secondary	Radiation Safety - fluoroscopy time	Assess radiation safety dose: Fluoroscopy time (FT)	Through study completion, an average of 1.5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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