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临床试验/NCT02572232
NCT02572232已完成不适用

Comparison of Three Different Supraglottic Airway Devices and Endotracheal Intubation in Pediatric Difficult Airway Situations in a Manikin

Medical University of Vienna0 个研究点目标入组 40 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Time to successful ventilation

研究概览

简要总结

The purpose of the study is to compare three supraglottic airway devices (Combitube, Easytube, laryngeal mask airway) to endotracheal intubation in a simulated difficult airway scenario in a pediatric manikin.

详细描述

Supraglottic airway devices (SAD) have been designed for the "cannot intubate, cannot ventilate" scenario in prehospital as well as intrahospital settings and are utilized in medical emergency services and emergency departments all over the world, not only for anticipated and unanticipated difficult airway situations but also as an airway device used by non-anesthesiologists or in situations where only limited practice is possible. Securing an airway in a pediatric emergency situation is crucial. Unfortunately, pediatricians usually lack the required skills and regular practice to perform endotracheal intubation (ETI, which is the gold standard for securing an airway) quickly and safely. SADs would pose a safe and feasible alternative to ETI. However, no studies on this topic are available. The investigators therefore wanted to evaluate three different SADs (Combitube, Easytube, laryngeal mask airway) in simulated difficult airway situations in a pediatric manikin in comparison to ETI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pediatricians
  • residents
  • written informed consent form

排除标准

  • 未提供

研究组 & 干预措施

Combitube, Easytube, Laryngeal masks

Experimental

Combitube, Easytube, Laryngeal mask airway are intubated in pediatric airway manikins by probands in randomized order.

干预措施: Combitube, Easytube, Laryngeal masks (Device)

结局指标

主要结局

Time to successful ventilation

时间窗: 1 min

次要结局

  • Success rate(1 min)
  • Re-assessment of success rate after 3 months(3 months)
  • Rating of the device (questionnaire)(1 min)
  • Re-assessment of time to successful ventilation after 3 months(3 months)

研究者

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

Michael Frass

Univ.Prof.Dr.

Medical University of Vienna

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