NCT04924621

Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways

Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways，A Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedative, Hypnotic, or Anxiolytic Withdrawal
• Airway Control

Interventions

Type	Name	Description
DEVICE	Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.	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.
DEVICE	Mask ventilation	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.
DRUG	Midazolam(T group)	Midazolam 0.05mg/kg, intravenous injection
DRUG	Sufentani(T group)	Sufentanil 0.02-0.05ug/kg, intravenous injection
DRUG	Propofol(T group)	Propofol 2-3ug/ml, intravenous injection
DRUG	Rocuronium(T group)	Rocuronium 0.06mg/kg, intravenous injection
DRUG	Drug use target(T group)	Make BIS \< 60 .
DRUG	Sufentanil(C group)	Sufentanil 5ug, intravenous injection
DRUG	Midazolam(C group)	Midazolam 0.05mg/kg, intravenous injection
DRUG	Propofol	Propofol 1-2ug/ml, intravenous injection
DRUG	Tetracaine(C group)	2ml tetracaine was injected with cyclothyroid membrane puncture.
DRUG	Drug use target	Make the BIS between 70 and 80.

Timeline

• Start date: 2021-06-10
• Primary completion: 2022-05-10
• Completion: 2022-06-10
• First posted: 2021-06-14
• Last updated: 2022-04-12

Locations

1 site across 1 country: China