High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery

December 26, 2023 updated by: Jong Yeop Kim, Ajou University School of Medicine

Comparison of High Flow Nasal Oxygenation Versus Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery

Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Laryngeal microsurgery is mainly performed by a conventional method of general anesthesia with endotracheal intubation (ET), which may have difficulty accessing the lesion behind the larynx, and may be limited in securing space for surgical manipulation. To compensate for these shortcomings, a method of maintaining general anesthesia without using an endotracheal tube has been introduced, and high-flow nasal oxygen(HFNO) and transnasal humidified rapid insufflation ventilatory exchange(THRIVE) enable tubeless anesthesia due to apnea oxygenation and apnea ventilation effect during laryngeal microsurgery. Coughing and straining can be accompanied by emergence after general anesthesia. Forceful vocal cord adduction especially after upper respiratory surgery such as laryngeal microsurgery can cause damage and bleeding of surgical tissue, delaying wound healing. If a small amount of remifentanil is continuously injected during emergence after total intravenous anesthesia(TIVA), airway complications such as coughing can be reduced during emergence without delay in recovery time, and hemodynamic stability can be promoted. In this study, the effect of endotracheal intubation and high-flow nasal oxygen on the emergence cough and postoperative sore throat is compared when total intravenous anesthesia(TIVA) using propofol and remifentanil is performed in patients undergoing laryngeal microsurgery. This study hypothesizes that in general anesthesia for laryngeal microsurgery, high-flow nasal oxygen without endotracheal intubation reduces cough during the emergence period compared to endotracheal intubation.

Study Type

Interventional

Enrollment (Estimated)

52

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 Contact Backup

  • Name: JongYeop Kim, M.D.,Ph.D.
  • Phone Number: 82-031-219-5574
  • Email: kjyeop@ajou.ac.kr

Study Locations

  • Korea, Republic of
    • Gyeongki-do
      • Suwon, Gyeongki-do, Korea, Republic of, 443-721
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Jong Yeop Kim, M.D., Ph.D.
        • Contact:
          • Tae Kwang Kim, M.D
        • Principal Investigator:
          • Jong Yeop Kim, M.D., Ph.D.

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia for laryngeal microsurgery

Exclusion Criteria:

  • Patients with major cardiovascular, pulmonary, and cerebrovascular disease
  • Laser laryngeal surgery
  • Morbid obesity (BMI>35 kg/m2)

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: HFNO group
Patients will receive HFNO therapy during laryngomicrosurgery.
Device: HFNO group
HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
Other Names:
  • Optiflow
Active Comparator: ET group
Endotracheal intubation was performed for general anesthesia
Device: ET group
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Other Names:
  • Portex, Smiths Medical International Ltd., South East England, United Kingdom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of Emergence cough during periextubation period
Time Frame: From end of surgery to extubation
Grade Score (grade 0=no cough, grade 1=light or single cough, grade 2=moderate cough or more than one episode of nonsustained coughing, grade 3=sustained and repetitive cough movements with head lift, 0 is the minimum value which is a better outcome and 3 is the maximum value which is a worse outcome.)
From end of surgery to extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with postoperative airway complications
Time Frame: from 1 hour after surgery to 24 hours after surgery
post operative sore throat
from 1 hour after surgery to 24 hours after surgery

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: JongYeop Kim, M.D.,Ph.D., Ajou University School of Medicine

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)

November 15, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJOUIRB-IV-2022-457

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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