Comparison of the CMAC® Device to the Airtraq® and the Macintosh Laryngoscope in Patients With Anatomical Characteristics Predictive of Difficult Tracheal Intubation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of successful placement of Tube in the Trachea
研究概览
简要总结
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where anatomical characteristics predictive of difficult intubation are present.
The CMAC® Laryngoscope is a new intubating device. It is designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
The CMAC may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of this device in comparison to the traditional Macintosh laryngoscope and other novel laryngoscopes is not known.
We aim to compare its performance to that of the Macintosh laryngoscope, the gold standard device, in patients with one or more anatomical characteristics predictive of difficult intubation.
The investigators further aim to compare it to the Airtraq® device a device which has been shown to be superior to the Macintosh laryngoscope in previous trials.
The investigators primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the CMAC than using the Macintosh laryngoscope in patients with two or more anatomical characteristics predictive of difficult intubation.
The investigators further hypothesize that the Airtraq® will be superior the CMAC® with one or more anatomical characteristics predictive of difficult intubation.
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
- •ASA 1-3 patients undergoing surgical procedures requiring orotracheal intubation.
- •Written informed Consent
- •No relevant drug allergies
- •Patients with 2 or more of the following predictors of difficult intubation:
- •Mallampatti II - IV
- •Thyromental distance < 6cm
- •Mouth opening < 3.5 cm
- •Cervical spine disease
- •Anteriorly protruding incisors
- •Presence of Caps or Crowns
排除标准
- •Patients with history of or risk factors for gastric regurgitation
- •Patients unable to consent for the trial
结局指标
主要结局
Rate of successful placement of Tube in the Trachea
时间窗: immediately
次要结局
- 1. Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds(immediately)
- 2. Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt(immediately)
- 3. Laryngeal View Obtained c. Cormac and Lehane Grading of Best Laryngeal View d. Change in view compared to initial assessment by independent anaesthetist. e. POGO score.(immediately)
研究者
John Laffey
Professor of Anaesthesia
University College Hospital Galway