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临床试验/NCT01374061
NCT01374061撤回4 期

Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®

Assistance Publique - Hôpitaux de Paris0 个研究点开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
主要终点
IDS score in each group

研究概览

简要总结

The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.

详细描述

Introduction

In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions.

Objectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method

Progress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.

研究设计

研究类型
Interventional
分配方式
Randomized
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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients of more than 18 years old
  • •requiring an intubation
  • •by medical out of hospital emergency operators
  • •medical insurance
  • •Consent signed

排除标准

  • •Age <18, pregnant women
  • •Refusal of consent or inability for understanding study
  • •small mouth opening makes it impossible intubate

研究组 & 干预措施

1: Classical intubation

Active Comparator

干预措施: Classical intubation (Device)

2: Glidescope intubation

Experimental

干预措施: GLIDESCOPE (Device)

结局指标

主要结局

IDS score in each group

时间窗: during the intubation

次要结局

  • Hemodynamic instability(per intubation)
  • Vomit / regurgitation or inhalation per-procedure(during the intubation)
  • Dental or throat traumatism(during the intubation)
  • Broncho/laryngospasm(during the intubation)
  • Hypoxia(per intubation)
  • Inhalation pneumonia(within 24 hours following the inclusion)
  • Failure of intubate(during the intubation)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Pre Hospital Evaluation of Video Laryngoscopy | 临床试验