Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Patient Outcomes
研究概览
简要总结
The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called "Flow Disruption Events" (FDs) with a potential risk to patient safety occur very often.
The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology.
Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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: Written consent, completed case
- •OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration
排除标准
- •OR visitors & students
结局指标
主要结局
Patient Outcomes
时间窗: 3 Months
Intra- and postoperative patient outcomes (Complications, functional outcomes etc.)
Intraoperative Teamwork
时间窗: 4 Hours
Teamwork within the medical team including surgeons, nurses and anaesthetists
Stress, Mental Workload
时间窗: 4 Hours
Intraoperative workload, perceived distraction and stress of medical team
次要结局
未报告次要终点
研究者
Matthias Weigl
Principal Investigator
Ludwig-Maximilians - University of Munich
