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

NCT ID: NCT04924621

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2022-06-10

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.

Conditions

Sedative, Hypnotic, or Anxiolytic Withdrawal; Airway Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

THRIVE group

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℃.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Midazolam(T group)

Intervention Type: DRUG

Midazolam 0.05mg/kg, intravenous injection

Sufentani(T group)

Intervention Type: DRUG

Sufentanil 0.02-0.05ug/kg, intravenous injection

Propofol(T group)

Intervention Type: DRUG

Propofol 2-3ug/ml, intravenous injection

Rocuronium(T group)

Intervention Type: DRUG

Rocuronium 0.06mg/kg, intravenous injection

Drug use target(T group)

Intervention Type: DRUG

Make BIS \< 60 .

Control group

The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes

Group Type: PLACEBO_COMPARATOR

Mask ventilation

Intervention Type: 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.

Sufentanil(C group)

Intervention Type: DRUG

Sufentanil 5ug, intravenous injection

Midazolam(C group)

Intervention Type: DRUG

Midazolam 0.05mg/kg, intravenous injection

Propofol

Intervention Type: DRUG

Propofol 1-2ug/ml, intravenous injection

Tetracaine(C group)

Intervention Type: DRUG

2ml tetracaine was injected with cyclothyroid membrane puncture.

Drug use target

Intervention Type: DRUG

Make the BIS between 70 and 80.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Midazolam(T group)

Midazolam 0.05mg/kg, intravenous injection

Intervention Type: DRUG

Sufentani(T group)

Sufentanil 0.02-0.05ug/kg, intravenous injection

Intervention Type: DRUG

Propofol(T group)

Propofol 2-3ug/ml, intravenous injection

Intervention Type: DRUG

Rocuronium(T group)

Rocuronium 0.06mg/kg, intravenous injection

Intervention Type: DRUG

Drug use target(T group)

Make BIS \< 60 .

Intervention Type: DRUG

Sufentanil(C group)

Sufentanil 5ug, intravenous injection

Intervention Type: DRUG

Midazolam(C group)

Midazolam 0.05mg/kg, intravenous injection

Intervention Type: DRUG

Propofol

Propofol 1-2ug/ml, intravenous injection

Intervention Type: DRUG

Tetracaine(C group)

2ml tetracaine was injected with cyclothyroid membrane puncture.

Intervention Type: DRUG

Drug use target

Make the BIS between 70 and 80.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yang Xudong

Chief of Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xudong Yang, MD

Role: CONTACT

kqyangxudong@163.com

62179977

Facility Contacts

Xudong Yang, MD

Role: primary

kqyangxudong@163.com

62179977

Zijian Guo, MS

Role: backup

guozijian1993@126.com

62179977

Other Identifiers

PKUSSIRB-202163045

Identifier Type: -

Identifier Source: org_study_id