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

ConditionsPatient Safety Endovascular Procedures Quality Improvement

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Ghent

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 population

Patients planned for endovascular intervention at Ghent University Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Massive Open Online Course (MOOC)
Other intervention
Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists

Treatment groups

400 Participants

are divided into 4 treatment groups

Group A: Pilot study0 interventions

Group B: Baseline measurement0 interventions

Group C: Post measurement1 intervention

Group D: Registry of endovascular cases0 interventions

Trial outcomes

Primary outcomes

Error

Evaluate errors during elective endovascular procedures in a hybrid room (error rate)

Time frame

Intraoperative errors will be measured per case through study completion, an average of 1.5 years.

Secondary outcomes

Technical skills - PVI

Assess technical skills of the surgeon on Global rating scale (range: 8-40) (the higher the score, the better)

Time frame