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

Airway Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04924621
• Other study ID #: PKUSSIRB-202163045
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: April 2022
• Source: Peking University
• Contact: Xudong Yang, MD
• Phone: 62179977
• Email: kqyangxudong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Control

Intervention

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.
• 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
• Sufentani(T group)
Sufentanil 0.02-0.05ug/kg, intravenous injection
• Propofol(T group)
Propofol 2-3ug/ml, intravenous injection
• Rocuronium(T group)
Rocuronium 0.06mg/kg, intravenous injection
• Drug use target(T group)
Make BIS < 60 .
• Sufentanil(C group)
Sufentanil 5ug, intravenous injection
• Midazolam(C group)
Midazolam 0.05mg/kg, intravenous injection
• Propofol
Propofol 1-2ug/ml, intravenous injection
• Tetracaine(C group)
2ml tetracaine was injected with cyclothyroid membrane puncture.
• Drug use target
Make the BIS between 70 and 80.

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen pressure	Blood oxygen pressure after intubation immediately.	Day 0
Primary	Pulse oxygen saturation	Pulse oxygen saturation after intubation immediately.	Day 0
Primary	Blood carbon dioxide pressure	Blood carbon dioxide pressure after intubation immediately.	Day 0
Secondary	Endtidal CO2	Endtidal CO2 at time point of TA?TB?TC?TD	Day 0
Secondary	Success of intubation	Proportion of successful endotracheal intubation	Day 0
Secondary	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
Secondary	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
Secondary	Time to complete intubation	Time required to complete endotracheal intubation	Day 0
Secondary	SPO2 below 95%	Percentage of patients with pulse oxygen saturation below 95% during the trial	Day 0
Secondary	SPO2 below 92%	Percentage of patients with pulse oxygen saturation below 92% during the trial	Day 0