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临床试验/NCT01664234
NCT01664234已完成不适用

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
time to oxygen saturation

研究概览

简要总结

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
1 Month 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • infants (0-2) difficult airways

排除标准

  • . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

结局指标

主要结局

time to oxygen saturation

时间窗: Day 1

The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.

次要结局

  • mean oxygenation comparison(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Plattner

M.D.

Medical University of Vienna

研究点 (2)

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