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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Error
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Error
时间窗: 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)
次要结局
- Technical skills - PVI(Through study completion, an average of 1.5 years)
- Technical skills - EVAR - GRS(Through study completion, an average of 1.5 years)
- Technical skills - EVAR - PRS(Through study completion, an average of 1.5 years)
- Technical skills - EVAR - EVARATE(Through study completion, an average of 1.5 years)
- Non-technical skills - surgical team(Through study completion, an average of 1.5 years)
- Non-technical skills - nursing team(Through study completion, an average of 1.5 years)
- Distractions - auditory(Through study completion, an average of 1.5 years)
- Distractions - people(Through study completion, an average of 1.5 years)
- Radiation Safety - fluoroscopy time(Through study completion, an average of 1.5 years)
- Distractions - doors(Through study completion, an average of 1.5 years)
- Radiation Safety - dose DAP(Through study completion, an average of 1.5 years)
- Radiation Safety - dose AK(Through study completion, an average of 1.5 years)
- Radiation Safety - behavior(Through study completion, an average of 1.5 years)
- Cognitive load(From January 1st 2023 until January 1st 2025)
- Error work culture(Through study completion, an average of 1.5 years)
- Psycho-social well-being(Through study completion, an average of 1.5 years)
- Incident reports(Through study completion, an average of 1.5 years)
- Technical Readiness and Acceptance(january 2023 until december 2025)