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临床试验/NCT01295749
NCT01295749已完成3 期

Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.

University Hospital, Grenoble4 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
84
试验地点
4
主要终点
comparison of no flow time between two strategies

研究概览

简要总结

International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.

In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.

详细描述

Multicentric, prospective, controlled, randomized study with parallel groups in single blind.

Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.

Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.

The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :

A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
  • more than 18 years
  • patient affiliated to the social security system or equivalent

排除标准

  • certain death
  • patient deprived of freedom by judicial or administrative decision
  • patient under legal protection
  • Pregnancy, parturient or breast feeding
  • facial trauma

结局指标

主要结局

comparison of no flow time between two strategies

时间窗: arrival of paramedical staff T0

group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest

次要结局

  • qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest(during cardiac arrest a T0)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (4)

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