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临床试验/NCT00378170
NCT00378170Unknown不适用

Laryngoscope Prototype Tested Against the Traditional Macintosh Blade

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
210
试验地点
2
主要终点
succes rate - immediate evaluation

研究概览

简要总结

The primary objective is to evaluate a knewly developed blade (for intubating patients about to undergo surgery) and compare it to the traditional Macintosh blade

详细描述

Intubation of patiens can be difficult, even impossible. It can result in different complications as damage to the teeth, lacerations of the mucosa, bleeding, fractures/luxations, hypoxia, hypercapnia, reflex bradycardia and in worst case braindamage and death.

The more difficult the intubation is the more frequent complicationrate. We believe to have developed a laryngoscopeblade that hopefully eases the intubationproces and thereby reduces the complicationrisk.

The patients included in this study is patients who are undergoing elective surgery requering intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

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

  • age over 18
  • ASA 1-III
  • Patients undergoing elective surgery requering intubation at KAS Herlev

排除标准

  • Prior difficult intubation indicating awake fiberoptic intubation
  • pathology in the airways predicting difficult intubation
  • columna cervicalis fractures
  • pregnancy
  • Requirement for Rapid sequence induction

结局指标

主要结局

succes rate - immediate evaluation

difficulty - immediate evaluation

次要结局

  • Interincissor gap
  • Cormack & Lehane grading
  • Time to intubate
  • vissible complication

研究者

申办方类型
Other

研究点 (2)

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