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临床试验/NCT07076511
NCT07076511已完成不适用

A Novel, Intuitive Airway Trolley to Facilitate Fast Decision Making in the Emergency Scenario "Unexpected Difficult Airway": Evaluation and Comparison to the Existing Airway Trolley in the Scope of a Simulation Training

Johannes Gutenberg University Mainz2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月1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
50
试验地点
2
主要终点
Time to emergency front of neck access (eFONA) decision (in s)

研究概览

简要总结

The goal of this study is to analyze the impact of color-coded labeling and cognitive visual aids of a novel airway trolley on the performance of participants in a simulated unexpected difficult airway scenario. All participants will complete the same scenario, randomized to either the novel or the existing airway trolley. The main questions aimed to be answered are:

  1. how long does it take to solve the scenario (=establish sufficient oxygenation via emergency front of neck access) with the novel vs the existing airway trolley?
  2. how many deviations from the algorithm "unexpected difficult airway" are documented for each trolley (novel vs existing)?
  3. are there differences in the provider experience between both trolleys

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
None

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

  • anaesthesiological 2nd and 3rd year residents at University Medical Centre Mainz
  • anaesthesiological attendings at University Medical Centre Mainz
  • informed written consent

排除标准

  • 未提供

结局指标

主要结局

Time to emergency front of neck access (eFONA) decision (in s)

时间窗: time (in seconds) until scenario is solved and decision to perform eFONA is verbalized (maximum time to solve scenario 10 minutes)

time to verbalized decision to perform eFONA defined as time to solving the scenario (in s)

次要结局

  • Gender differences in the time until eFONA(Maximum time to solve the scenario: 10 minutes)
  • subjective work load evaluation(To be filled out after completing the scenario (time given: 3 minutes))
  • Time to decision to prepare eFONA (in sec)(time (in seconds) when decision to prepare eFONA is verbalized (maximum time to solve scenario 10 minutes))
  • number of departures from difficult airway algorithm(Through the course of the scenario (maximum time for completion 10 minutes))
  • Time to establish successful oxygenation (in seconds)(Maximum time to solve scenario: 10 minutes)
  • Gender differences in number of departures from difficult airway algorithm(Maximum time to solve the scenario: 10 minutes)
  • number of unnecessary drawer opening(Through the course of the scenario (maximum time for completion 10 minutes))
  • subjective operator experience(To be filled out after completing the scenario (time given: 3 minutes))

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katharina Epp

Principal Investigator

Johannes Gutenberg University Mainz

研究点 (2)

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