Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 主要终点
- Rate of successful intubation at the first attempt
研究概览
简要总结
In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients.
To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated.
As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself.
Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation.
Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate.
Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy.
Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications.
The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy.
The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.
Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age more than 18
- •Indication of orotracheal intubation
- •Operators trained to the use of the McGrath
排除标准
- •Pregnancy
- •No insurance
- •Major patient under guardianship or curatorship
结局指标
主要结局
Rate of successful intubation at the first attempt
时间窗: up to 10 minutes post inclusion
One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
次要结局
- Number of attempts needed for successful intubation(up to 10 minutes post inclusion)
- Proportion of difficult intubations(up to 10 minutes post inclusion)
- Type of complications per and post-intubation(up to 10 minutes post inclusion)
- Time to intubate(up to 10 minutes post inclusion)
- Reason of failure of the first-pass success(up to 10 minutes post inclusion)
- Glottic view(up to 10 minutes post inclusion)
- Proportion of cases needed crossovers to other rescue techniques(up to 10 minutes post inclusion)
- Proportion of cases who need for tools to optimize(up to 10 minutes post inclusion)
- Proportion of decision of switch in case of failure(up to 10 minutes post inclusion)
- Number of deaths(up to 10 minutes post inclusion)
- Number of complications per and post-intubation(up to 10 minutes post inclusion)