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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Belgium
UZ Gent
RECRUITING
Ghent
Contact Information
Primary
Isabelle Van Herzeele, MD, PhD
isabelle.vanherzeele@ugent.be
093325108
Time Frame
Start Date: 2019-02-19
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 222
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University Ghent
Collaborators: University of Toronto

This content was sourced from clinicaltrials.gov