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临床试验/NCT03542747
NCT03542747已完成不适用

Comparison of the Novel iLTS and Fastrach Intubation Laryngeal Mask for Time to Ventilation in a Simulated Airway.

Johannes Gutenberg University Mainz1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年6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
发起方
入组人数
160
试验地点
1
主要终点
Time to ventilation via endotracheal tube

研究概览

简要总结

Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach

详细描述

Prior to the study every participant obtained a standardized instruction of each device. In the proposed clinical trial the primary study objective will be to determine whether there is a difference in time to ventilation via endotracheal tube (seconds) for the novel iLTS-D compared to the LMA Fastrach. Time to Ventilation will be defined from when the tip of the extraglottic airway device passed the incisors to the point until confirmation the first chest rise of the high fidelity simulator (Laerdal SimMan). Additionally, two time points before final tracheal placement will evaluated: time to place the EGA and time to ventilate with the EGA after introducing the device into the oral cavity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Medical students
  • •Present written informed consent of the research participant

排除标准

  • •inability to consent

研究组 & 干预措施

Time to ventilation with the iLTS

Experimental

Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds

干预措施: Time to ventilation with the iLTS (Device)

Time to ventilation with the iLTS

Experimental

Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds

干预措施: Time to ventilation with the Fastrach (Device)

Time to ventilation with the Fastrach

Experimental

Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

干预措施: Time to ventilation with the iLTS (Device)

Time to ventilation with the Fastrach

Experimental

Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

干预措施: Time to ventilation with the Fastrach (Device)

结局指标

主要结局

Time to ventilation via endotracheal tube

时间窗: 0 to 300 seconds

time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise

次要结局

  • Ease of Insertion(0 to 420 seconds)
  • Time to ventilation via extraglottic airway device(0 to 300 seconds)
  • Intubation attempts(0 to 300 seconds)

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

Marc Kriege, MD

MD

Johannes Gutenberg University Mainz

研究点 (1)

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