A Randomised Controlled Trial to Compare McGrath Videolaryngoscope Against Direct Laryngoscope for Endotracheal Intubation When Powered Air Purifying Respirator is Worn During the Current Coronavirus Disease 2019 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Time to intubation for McGrath videolaryngoscope versus direct laryngoscope
研究概览
简要总结
Various guidelines for endotracheal intubation (insertion of breathing tube for mechanical ventilation) of Coronavirus Disease 2019 (COVID-19) patients recommend the use of videolaryngoscope (medical device used for intubation that has a camera to visualize the vocal cords between which the breathing tube will pass) over direct laryngoscope (conventionally-used medical device for intubation that depends on anesthetist's direct visualization of vocal cords). The reasons for this recommendation are to maximize the distance between the medical personnel and the patient's face during intubation to decrease the risk of viral particles transmission and to improve intubation success.
For patients infected with COVID-19, Powered Air Purifying Respirator (PAPR) is recommended as an alternative to N95 masks during aerosol-generating procedures such as intubation because N95 masks may not fully protect medical personnel from viral transmission during intubation.
There is no evidence to suggest that videolaryngoscope (VL) is superior to direct laryngoscope (DL) for intubation when PAPR is donned.
The purpose of this study is to determine if McGrath VL is superior to DL for intubation when the anesthetist is wearing a PAPR. The investigators' hypothesis is that McGrath VL will decrease the time to intubation by 20 seconds and more compared to DL when PAPR is donned. The investigators also hope to learn if there is any difference in the difficulties encountered between the use of VL and DL.
详细描述
Background:
17% of patients with Coronavirus Disease 2019 (COVID-19) may require endotracheal intubation for mechanical ventilation due to respiratory failure.
Various guidelines for endotracheal intubation of COVID-19 patients recommend the use of videolaryngoscope (VL) over direct laryngoscope (DL). The reasons for this recommendation are to firstly, maximize the distance between the medical personnel and the patient's face during intubation in order to decrease the risk of viral particles transmission and secondly, to improve intubation success.
There is a lack of evidence to show that VL can decrease the risk of contact with aerosol generated during intubation. Matthew T.V. Chan et al have shown that aerosol may be generated up to 45cm away from the patient's face during intubation. In the investigators' own trial run of an experimental set-up to study the difference in intubation between VL and DL when PAPR is worn, the investigators found that it is not possible to maintain a distance of at least 45cm during the intubation process because of the need to visualize the entry of the laryngoscope blade into the patient's mouth in order to prevent injury to the oral structures. The investigators' study is congruent with a recent study that reports the mean distance from the patient's mouth to anesthetist's mouth was 35.6cm using VL and 16.4cm using DL.
In routine intubations, VL is recommended over DL for endotracheal intubation as it may provide a higher success and faster speed of intubation compared to DL. For patients infected with COVID-19, PAPR is recommended as an alternative to N95 masks during aerosol-generating procedures such as intubation because N95 masks may not fully protect medical personnel from viral transmission during intubation. There is currently no evidence to suggest that VL is superior to DL for intubation when PAPR is donned.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patients who have consented for the operation will not know which laryngoscope (either McGrath videolaryngoscope or direct laryngoscope) was used for their intubation. The outcomes assessor will not know which group the patients and the anesthetists are in when analysing the results.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to intubation for McGrath videolaryngoscope versus direct laryngoscope
时间窗: During the intubation process
The time to intubation starts from the time the anesthetist takes over the laryngoscope till the first appearance of consecutive capnography tracings. The time to intubation will be assessed via a retrospective playback of the video-recording of the intubation process. Compares the time to intubation for McGrath videolaryngoscope against direct laryngoscope.
次要结局
- Incidence of success and failure at intubation using initial laryngoscope(During the intubation process)
- Incidence of the use of adjuncts at first attempt with McGrath videolaryngoscope versus direct laryngoscope(During the intubation process)
- Incidence of success at first intubation attempt with McGrath videolaryngoscope versus direct laryngoscope(During the intubation process)
- Intubation Difficulty Scale with McGrath videolaryngoscope versus direct laryngoscope(During the intubation process)
- Closest distance from the patient's mouth to the anaesthetist's mouth during intubation(During the intubation process)
- Incidence of the use of adjuncts at subsequent attempts with McGrath videolaryngoscope versus direct laryngoscope(During the intubation process)
- Incidence of oxygen desaturation to less than 88% and oro-dental injuries with McGrath videolaryngoscope versus direct laryngoscope.(During the intubation process.)
- Incidence of inability to intubate despite all efforts by the anesthetist with McGrath videolaryngoscope versus direct laryngoscope(During the intubation process)