Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
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
- 否
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
Olga Plattner
M.D.
Medical University of Vienna
