Bougie Use in Emergency Airway Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 757
- 试验地点
- 2
- 主要终点
- Number of Participants With First Pass Success
研究概览
简要总结
This prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.
详细描述
The primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway).
We will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic.
We plan to enroll 374 patients with a difficult airway characteristic (DAC). The total enrollment for the trial will be higher, depending on the proportion of patients that have a DAC.
Based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a DAC.
To help achieve balanced randomization for patients with a DAC, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy)
- •The patient must be presumed to be 18 years of age or older at the time of enrollment.
排除标准
- •Known anatomic distortion of the upper airway or perilaryngeal structures.
- •Prisoner or under arrest
- •Known or suspected to be pregnant, based on the opinion of the treating physician.
研究组 & 干预措施
Bougie
On the first intubation attempt, this arm will attempt to place a bougie into the trachea, followed by an endotracheal tube.
干预措施: Bougie (Device)
No bougie (endotracheal tube first)
On the first intubation attempt, this arm will attempt to place an endotracheal tube into the trachea directly.
干预措施: Endotracheal tube (Device)
结局指标
主要结局
Number of Participants With First Pass Success
时间窗: 5 minutes
First pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur: 1. the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie. 2. if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth. A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt.
次要结局
- Esophageal Intubation(5 minutes)
- First Pass Success Without Hypoxemia(5 minutes)
- Time to Intubation (First Attempt)(5 minutes)
- Hypoxemia(5 minutes)
研究者
Brian Driver
Associate Research Director
Hennepin Healthcare Research Institute