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临床试验/NCT04226391
NCT04226391已完成不适用

Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2020年1月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Weigl

Principal Investigator

Ludwig-Maximilians - University of Munich

研究点 (1)

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