Pre Hospital Evaluation of Video Laryngoscopy (EVE)
Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
研究概览
地位
详细说明
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.
研究类型
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients of more than 18 years old
- requiring an intubation
- by medical out of hospital emergency operators
- medical insurance
- Consent signed
Exclusion Criteria:
- Age <18, pregnant women
- Refusal of consent or inability for understanding study
- small mouth opening makes it impossible intubate
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:1: Classical intubation
|
Classical intubation
|
|
实验性的:2: Glidescope intubation
|
GLIDESCOPE intubation
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
IDS score in each group
大体时间:during the intubation
|
during the intubation
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Vomit / regurgitation or inhalation per-procedure
大体时间:during the intubation
|
during the intubation
|
|
Dental or throat traumatism
大体时间:during the intubation
|
during the intubation
|
|
Broncho/laryngospasm
大体时间:during the intubation
|
during the intubation
|
|
Hypoxia
大体时间:per intubation
|
per intubation
|
|
Hemodynamic instability
大体时间:per intubation
|
per intubation
|
|
Inhalation pneumonia
大体时间:within 24 hours following the inclusion
|
within 24 hours following the inclusion
|
|
Failure of intubate
大体时间:during the intubation
|
during the intubation
|
合作者和调查者
调查人员
- 研究主任:Patrick PLAISANCE, MD, PhD、Assistance Publique - Hôpitaux de Paris
- 首席研究员:Sébastien GALLULA, Ph、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- P100205
- 2010-A01512-37 (其他标识符:IDRCB)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.