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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE group | Experimental | 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℃. |
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| Control group | Placebo Comparator | The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc. | Device | The nasal cavity was disinfected with Iodophor cotton swab, and the appropriate nasal cavity was selected for endotracheal intubation assisted by fiberoptic bronchoscope according to the experience of anesthesiologists. After the endotracheal intubation was fixed, the anesthesia machine was connected for mechanical ventilation. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood oxygen pressure | Blood oxygen pressure after intubation immediately. | Day 0 |
| Pulse oxygen saturation | Pulse oxygen saturation after intubation immediately. | Day 0 |
| Blood carbon dioxide pressure | Blood carbon dioxide pressure after intubation immediately. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Endtidal CO2 | Endtidal CO2 at time point of TA、TB、TC、TD | Day 0 |
| Success of intubation | Proportion of successful endotracheal intubation |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xudong Yang, MD | Contact | 62179977 | kqyangxudong@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Hospital of Stomatology | Recruiting | Beijing | Beijing Municipality | 100081 | China |
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| Mask ventilation | Device | The Control Group will receive sequential intravenous infusion of Sufentanil 5ug, midazolam 0.05mg/kg, and propofol 1-2ug/ml, to make the BIS between 70 and 80. 2ml tetracaine was injected with cyclothyroid membrane puncture, and the nasal cavity was disinfected with iodophor cotton swab. According to the experience of anesthesiologists, the appropriate nasal cavity was selected for intranasal endotracheal intubation assisted by fiberbronchoscope. After the endotracheal intubation was successful, the anesthesia machine was connected for mechanical ventilation, full narcotic inducer will be injected. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg. |
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| Midazolam(T group) | Drug | Midazolam 0.05mg/kg, intravenous injection |
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| Sufentani(T group) | Drug | Sufentanil 0.02-0.05ug/kg, intravenous injection |
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| Propofol(T group) | Drug | Propofol 2-3ug/ml, intravenous injection |
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| Rocuronium(T group) | Drug | Rocuronium 0.06mg/kg, intravenous injection |
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| Drug use target(T group) | Drug | Make BIS < 60 . |
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| Sufentanil(C group) | Drug | Sufentanil 5ug, intravenous injection |
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| Midazolam(C group) | Drug | Midazolam 0.05mg/kg, intravenous injection |
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| Propofol | Drug | Propofol 1-2ug/ml, intravenous injection |
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| Tetracaine(C group) | Drug | 2ml tetracaine was injected with cyclothyroid membrane puncture. |
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| Drug use target | Drug | Make the BIS between 70 and 80. |
|
| Day 0 |
| Arrhythmias or dramatic haemodynamic fluctuations | 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. | Day 0 |
| Tolerance of intubation | 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) | Day 1 |
| Time to complete intubation | Time required to complete endotracheal intubation | Day 0 |
| SPO2 below 95% | Percentage of patients with pulse oxygen saturation below 95% during the trial | Day 0 |
| SPO2 below 92% | Percentage of patients with pulse oxygen saturation below 92% during the trial | Day 0 |
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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