Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways
- Conditions
- Sedative, Hypnotic, or Anxiolytic WithdrawalAirway Control
- Interventions
- Device: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.Device: Mask ventilationDrug: Midazolam(T group)Drug: Sufentanil(C group)Drug: Sufentani(T group)Drug: Midazolam(C group)Drug: Propofol(T group)Drug: Rocuronium(T group)Drug: Tetracaine(C group)Drug: Drug use target(T group)Drug: Drug use target
- Registration Number
- NCT04924621
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description THRIVE group Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc. 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℃. THRIVE group Midazolam(T 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℃. THRIVE group Sufentani(T 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℃. THRIVE group Propofol(T 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℃. THRIVE group Rocuronium(T 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℃. THRIVE group Drug use target(T 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℃. Control group Mask ventilation The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Control group Sufentanil(C group) The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Control group Midazolam(C group) The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Control group Tetracaine(C group) The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Control group Drug use target The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes Control group Propofol The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
- Primary Outcome Measures
Name Time Method Blood oxygen pressure Day 0 Blood oxygen pressure after intubation immediately.
Pulse oxygen saturation Day 0 Pulse oxygen saturation after intubation immediately.
Blood carbon dioxide pressure Day 0 Blood carbon dioxide pressure after intubation immediately.
- Secondary Outcome Measures
Name Time Method SPO2 below 95% Day 0 Percentage of patients with pulse oxygen saturation below 95% during the trial
Endtidal CO2 Day 0 Endtidal CO2 at time point of TA、TB、TC、TD
Success of intubation Day 0 Proportion of successful endotracheal intubation
Tolerance of intubation Day 1 The score of patient's tolerance to endotracheal intubation one day after surgery (0-10 points, 0 point is completely intolerable, 10 point is completely intolerable)
SPO2 below 92% Day 0 Percentage of patients with pulse oxygen saturation below 92% during the trial
Arrhythmias or dramatic haemodynamic fluctuations Day 0 Arrhythmias and dramatic fluctuations in heart rate and blood pressure: types and times of arrhythmias in the test were recorded. Changes in heart rate and blood pressure more than 30% before surgery were recorded as dramatic fluctuations.
Time to complete intubation Day 0 Time required to complete endotracheal intubation
Trial Locations
- Locations (1)
Peking University Hospital of Stomatology
🇨🇳Beijing, Beijing, China