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

Peking University

Status

Unknown

Conditions

Airway Control

Sedative, Hypnotic, or Anxiolytic Withdrawal

Treatments

Drug: Propofol

Device: Mask ventilation

Drug: Sufentanil(C group)

Drug: Sufentani(T group)

Drug: Rocuronium(T group)

Drug: Midazolam(C group)

Drug: Drug use target

Drug: Midazolam(T group)

Device: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.

Drug: Propofol(T group)

Drug: Drug use target(T group)

Drug: Tetracaine(C group)

Study type

Interventional

Funder types

Other

Identifiers

NCT04924621

PKUSSIRB-202163045

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Age 18-60
Patients with difficult airway assessed by two anesthesiologists according to the difficult airway score who needed to undergo nasal endotracheal intubation for oral and maxillofacial surgery in Peking University Stomatological Hospital.
BMI between 18 to 30 kg/m2
ASA Grade I to II
NYHA grade I
Patients requiring arterial hemodynamics monitoring and blood gas analysis due to surgical requirements
Signed the informed consent

Exclusion Criteria

Respiratory diseases: respiratory failure, COPD, pulmonary fibrosis, asthma and other diseases. Patients with ventilatory dysfunction or airway obstruction.
NYHA cardiac function grade greater than I, or NYHA cardiac function grade I but with a history of coronary heart disease.
Conditions affecting the monitoring of peripheral oxygen saturation, such as poor peripheral circulation perfusion and application of vasoconstrictor, are present.
Indoor oxygen saturation below 92%.
Patients who cannot tolerate rapid exchange ventilation with nasal humidification.
Patients with a history of easy nasal bleeding.
Inability to understand or express pain scores.
Menstrual period and lactation period of female patients.
The patient has mental illness.
Patients with severe intraoperative complications should be removed after surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups, including a placebo group

THRIVE group

Experimental group

Description:

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℃.

Treatment: