Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways，A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pulse oxygen saturation
研究概览
简要总结
To compare the difference in endotracheal intubation in participants with difficult airway between under general anesthesia by Transnasal Humidified Rapid-Insufflation Ventilatory Exchange and under traditional sedation by mask ventilation. The investigators focus on the different outcomes in oxygenation maintaince, carbon dioxide removal and the effectiveness of safety apnea time, to evaluate the safety of receiving endotracheal intubation under general anesthesia in participants with difficult airway.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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
研究组 & 干预措施
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc. (Device)
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Midazolam(T group) (Drug)
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Sufentani(T group) (Drug)
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Propofol(T group) (Drug)
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Rocuronium(T group) (Drug)
THRIVE group
Patients in group T received mask ventilation(oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes, and then THRIVE device (device model: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.) was set 100% oxygen, flow rate 30L /min, temperature 34℃.
干预措施: Drug use target(T group) (Drug)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Mask ventilation (Device)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Sufentanil(C group) (Drug)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Midazolam(C group) (Drug)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Propofol (Drug)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Tetracaine(C group) (Drug)
Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
干预措施: Drug use target (Drug)
结局指标
主要结局
Pulse oxygen saturation
时间窗: Day 0
Pulse oxygen saturation after intubation immediately.
Blood oxygen pressure
时间窗: Day 0
Blood oxygen pressure after intubation immediately.
Blood carbon dioxide pressure
时间窗: Day 0
Blood carbon dioxide pressure after intubation immediately.
次要结局
- Endtidal CO2(Day 0)
- Success of intubation(Day 0)
- Tolerance of intubation(Day 1)
- SPO2 below 92%(Day 0)
- Arrhythmias or dramatic haemodynamic fluctuations(Day 0)
- Time to complete intubation(Day 0)
- SPO2 below 95%(Day 0)
研究者
Yang Xudong
Chief of Department of Anesthesiology
Peking University