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临床试验/NCT03486171
NCT03486171Unknown不适用

Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context

University Hospital, Bordeaux5 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
5
主要终点
Difficult intubation rate

研究概览

简要总结

In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

详细描述

National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.

Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. The follow up will be restricted to the area of prehospital emergency setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients intubated by Emergency Medical System (EMS) team

排除标准

  • 未提供

结局指标

主要结局

Difficult intubation rate

时间窗: One hour

Difficult intubation is defined with an Intubation Difficult Scale score \> 5; Intubation Difficult Sale (IDS) is ranged from 0 (easy intubation) to infinity (impossibility to intubate trachea).

次要结局

  • Events during and after intubation(one hour)
  • Risk factors of difficult intubation(one hour)
  • Patient characteristics(one hour)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel GALINSKI

Principal investigator

University Hospital, Bordeaux

研究点 (5)

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