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临床试验/NCT07427641
NCT07427641尚未招募不适用

LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study

Rennes University Hospital0 个研究点目标入组 54 人开始时间: 2026年2月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
主要终点
Evolution of team performance on non-technicals skills

研究概览

简要总结

This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. The intervention is based on principles of crisis resource management and cognitive load theory. Team performance will be assessed using validated scoring tools immediately after the intervention and at three months follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The teams participating in the simulation sessions are composed as follows:
  • A senior doctor identified as the "medical leader"
  • An anaesthesia and intensive care intern
  • A state-registered nurse anaesthetist
  • Inclusion Criteria:
  • Participants with at least two years' experience in the specialty.
  • a. For interns, an additional requirement is that they must have completed a semester in intensive care.
  • Recruited via simulation trainers at their respective hospitals or university hospitals.

排除标准

  • The study cannot be carried out during a safety rest period (i.e. the day after being on call).

研究组 & 干预措施

Visual deprivation

Experimental

the designated team leader performs the simulated scenario while wearing visual deprivation mask.

干预措施: Visual deprivation (Behavioral)

No visual deprivation

No Intervention

Control group leaders perform the scenario without visual deprivation.

结局指标

主要结局

Evolution of team performance on non-technicals skills

时间窗: Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month

Team performance on non-technicals skills measured using the validated Team emergency Assessment Measure (TEAM) score assessed by blinded independent evaluators based on video recordings. TEAM score goes from 0 to 54 : 0 being the lowest level of non-technical competence (worst outcome) and 54 being the highest (better outcome)

次要结局

  • Evolution of team's clinical performance(Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month)
  • Evolution of medical leadership skills(Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month)
  • Clinical transferability of soft skills training in clinical practice(Immediately after the intervention at day 1 and at 3 month)
  • Evolution of theoretical knowledge of soft skills(At the end of the intervention at day 1 and at 3 month)
  • Assessment of anxiety induced by the intervention(At the end of the intervention at day 1)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

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