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临床试验/NCT06640595
NCT06640595已完成不适用

Simulation Study on Advanced Medical Procedures Under Extreme Environments

Institute of Mountain Emergency Medicine1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Difference in Time to perform the procedure

研究概览

简要总结

Background:

In emergency situations in mountainous regions, medical professionals are often required to perform advanced medical procedures swiftly and efficiently. The choice of procedure and the environmental conditions can significantly impact the patient outcomes. This study seeks to evaluate the effectiveness of three advanced emergency medical procedures in a simulated scenario: orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under both normal and cold temperature conditions.

Methods:

On 16 and 17 October 2023, members of the Medical Commission of the International Commission for Alpine Rescue performed a simulation training in an extreme environmental simulation chamber (terraXcube) in Bolzano, Italy. During this, each participant will perform three advanced medical procedures, once under normal environmental conditions (+20°C) and once under cold temperature conditions (-20°C), in randomized order and with a crossover design. Specifically, the three advanced medical procedures consist of 1) simulation of a difficult orotracheal intubation on a dedicated mannikin with a videolaryngoscope; 2) front of neck access (FONA) with the scalpel-finger-bougie technique on a dedicated mannikin model; 3) minithoracotomy and chest tube placement on a dedicated mannikin model.

Outcomes:

Primary outcome:

The primary outcome is the difference in time required for three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C).

Secondary outcomes:

Secondary outcomes include the success rate for three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C). Moreover, the subjective difficulty of performing the procedures, stress levels, emotional regualtion and decision-making process will be assessed through a questionnaire.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

入选标准

  • Members of the Medical Commission of the International Commission for Alpine Rescue (ICAR)

排除标准

  • Contraindications for exposure to cold temperatures

结局指标

主要结局

Difference in Time to perform the procedure

时间窗: During the performance of the procedure

Difference in time required to perform three different advanced medical procedures, i.e. orotracheal intubation with a videolaryngoscopy, minithoracotomy, and front of neck access, under normal environmental conditions (+20°C) compared to cold temperature (-20°C).

次要结局

  • Success rate(During the procedure)
  • Stress level(Immediately after the performance of the procedure)

研究者

发起方
Institute of Mountain Emergency Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Rauch

Senior Researcher

Institute of Mountain Emergency Medicine

研究点 (1)

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