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临床试验/NCT00644722
NCT00644722已完成4 期

Out-of-Hospital Intubation in Emergency Conditions With Either Metal Single Use or Reusable Laryngoscope Blades : Impact on Intubation Difficulties

Henri Mondor University Hospital2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
800
试验地点
2
主要终点
Intubation success rate during at the first laryngoscopy

研究概览

简要总结

New single use laryngoscope metal blades are available for intubation. This type of blade is safer than the reusable ones concerning the interhuman cross infection risk. No clinical studies have compared the two types of blades in the emergency context. The primary aim of this study is to demonstrate that single use blades are as efficient as the reusable ones concerning intubation conditions.

详细描述

All adult patients requiring tracheal intubation in the pre hospital emergency context will be included. All intubation will be performed by an emergency physician or a nurse specialized in anesthesia. For patients with spontaneous cardiac activity, rapid sequence intubation will be performed to allow intubation.

Comparisons studied will be : Intubation success rate at the first laryngoscopy, glottis exposure assessed by Cormack and Lehane classification, difficult intubation rate assessed by the Intubation Difficult Score (IDS), the need for alternative airway techniques and the immediate post intubation complications rate as vomiting, dental trauma, pulmonary inhalation, arterial desaturation , hypotension episodes and cardiac arrest occurrence.

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
Single (Participant)

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

  • All adult patients requiring out-of-hospital intubation

排除标准

  • Patient under 18 years old
  • Patients with criteria predictive of impossible intubation under direct laryngoscopy

结局指标

主要结局

Intubation success rate during at the first laryngoscopy

时间窗: 10 min

次要结局

  • glottis exposure assessed by Cormack and Lehane classification(1 day)
  • difficult intubation rate assessed by the Intubation Difficult Score (IDS)(1 day)
  • the need for alternative airway techniques and the immediate post intubation complications rate(1 day)

研究者

发起方
Henri Mondor University Hospital
申办方类型
Other

研究点 (2)

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