Clinical trial NCT04924621: Sedation Compaired With Anesthesia With THRIVE in Endotracheal Intubation With Difficult Airways
Official title: Conventional Sedation Compaired With THRIVE Under General Anesthesia in Endotracheal Intubation by Fiberbronchoscope in Patients With Difficult Airways，A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedative, Hypnotic, or Anxiolytic Withdrawal
Airway Control
Keywords: Moderate Sedative
Airway Control
THRIVE
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Blood oxygen pressure
timeFrame: Day 0
measure: Pulse oxygen saturation
timeFrame: Day 0
measure: Blood carbon dioxide pressure
timeFrame: Day 0
Secondary outcomes:
measure: Endtidal CO2
timeFrame: Day 0
measure: Success of intubation
timeFrame: Day 0
measure: Arrhythmias or dramatic haemodynamic fluctuations
timeFrame: Day 0
measure: Tolerance of intubation
timeFrame: Day 1
measure: Time to complete intubation
timeFrame: Day 0
measure: SPO2 below 95%
timeFrame: Day 0
measure: SPO2 below 92%
timeFrame: Day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
Study officials:
References: