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

April 4, 2022 updated by: Yang Xudong, Peking University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Recruiting
        • Peking University Hospital of stomatology
        • Principal Investigator:
          • Xudong Yang, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Zijian Guo, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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℃.
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.

Drug: Midazolam(T group)
Midazolam 0.05mg/kg, intravenous injection
Drug: Sufentani(T group)
Sufentanil 0.02-0.05ug/kg, intravenous injection
Drug: Propofol(T group)
Propofol 2-3ug/ml, intravenous injection
Drug: Rocuronium(T group)
Rocuronium 0.06mg/kg, intravenous injection
Drug: Drug use target(T group)
Make BIS < 60 .
Placebo Comparator: Control group
The Control Group will receive mask ventilation (oxygen concentration: 100%, flow rate: 6L /min, head height: 30°) for 5 minutes
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.
Drug: Sufentanil(C group)
Sufentanil 5ug, intravenous injection
Drug: Midazolam(C group)
Midazolam 0.05mg/kg, intravenous injection
Drug: Propofol
Propofol 1-2ug/ml, intravenous injection
Drug: Tetracaine(C group)
2ml tetracaine was injected with cyclothyroid membrane puncture.
Drug: Drug use target
Make the BIS between 70 and 80.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood oxygen pressure
Time Frame: Day 0
Blood oxygen pressure after intubation immediately.
Day 0
Pulse oxygen saturation
Time Frame: Day 0
Pulse oxygen saturation after intubation immediately.
Day 0
Blood carbon dioxide pressure
Time Frame: Day 0
Blood carbon dioxide pressure after intubation immediately.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endtidal CO2
Time Frame: Day 0
Endtidal CO2 at time point of TA、TB、TC、TD
Day 0
Success of intubation
Time Frame: Day 0
Proportion of successful endotracheal intubation
Day 0
Arrhythmias or dramatic haemodynamic fluctuations
Time Frame: Day 0
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
Tolerance of intubation
Time Frame: Day 1
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
Time to complete intubation
Time Frame: Day 0
Time required to complete endotracheal intubation
Day 0
SPO2 below 95%
Time Frame: Day 0
Percentage of patients with pulse oxygen saturation below 95% during the trial
Day 0
SPO2 below 92%
Time Frame: Day 0
Percentage of patients with pulse oxygen saturation below 92% during the trial
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Anticipated)

May 10, 2022

Study Completion (Anticipated)

June 10, 2022

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUSSIRB-202163045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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