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

NCT04924621 | Unknown

• 1 other identifier: PKUSSIRB-202163045
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Moderate Sedative; Airway Control; THRIVE

Outcome Measures

Primary Outcomes (3)

• Blood oxygen pressure

  Blood oxygen pressure after intubation immediately.

  Day 0

• Pulse oxygen saturation

  Pulse oxygen saturation after intubation immediately.

  Day 0

• Blood carbon dioxide pressure

  Blood carbon dioxide pressure after intubation immediately.

  Day 0

Secondary Outcomes (7)

• Endtidal CO2

  Day 0

• Success of intubation

  Day 0

• Arrhythmias or dramatic haemodynamic fluctuations

  Day 0

• Tolerance of intubation

  Day 1

• Time to complete intubation

  Day 0

Study Arms (2)

THRIVE group

EXPERIMENTAL

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℃.

Device: Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.; Drug: Midazolam(T group); Drug: Sufentani(T group); Drug: Propofol(T group); Drug: Rocuronium(T group); Drug: Drug use target(T group)

Control group

PLACEBO COMPARATOR

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

Device: Mask ventilation; Drug: Sufentanil(C group); Drug: Midazolam(C group); Drug: Propofol; Drug: Tetracaine(C group); Drug: Drug use target

Interventions

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

THRIVE group

Mask ventilation 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.

Control group

Midazolam(T group) DRUG

Midazolam 0.05mg/kg, intravenous injection

THRIVE group

Sufentani(T group) DRUG

Sufentanil 0.02-0.05ug/kg, intravenous injection

THRIVE group

Propofol(T group) DRUG

Propofol 2-3ug/ml, intravenous injection

THRIVE group

Rocuronium(T group) DRUG

Rocuronium 0.06mg/kg, intravenous injection

THRIVE group

Drug use target(T group) DRUG

Make BIS \< 60 .

THRIVE group

Sufentanil(C group) DRUG

Sufentanil 5ug, intravenous injection

Control group

Midazolam(C group) DRUG

Midazolam 0.05mg/kg, intravenous injection

Control group

Propofol DRUG

Propofol 1-2ug/ml, intravenous injection

Control group

Tetracaine(C group) DRUG

2ml tetracaine was injected with cyclothyroid membrane puncture.

Control group

Drug use target DRUG

Make the BIS between 70 and 80.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Xudong Yang, MD

CONTACT

62179977; kqyangxudong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Anesthesiology

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 14, 2021
• Study Start: June 10, 2021
• Primary Completion: May 10, 2022
• Study Completion: June 10, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)