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

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05559502
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
7.5
Anticipated Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HFNO group
  • Device: ET group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of High Flow Nasal Oxygenation Versus Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Grade of Emergence cough during periextubation period [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.)

    Secondary Outcome Measures

    1. Number of Participants with postoperative airway complications [from 1 hour after surgery to 24 hours after surgery]

      post operative sore throat

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ajou University Hospital Suwon Gyeongki-do Korea, Republic of 443-721

    Sponsors and Collaborators

    • Ajou University School of Medicine

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jong Yeop Kim, Professor, Ajou University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT05559502
    Other Study ID Numbers:
    • AJOUIRB-IV-2022-457
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jong Yeop Kim, Professor, Ajou University School of Medicine
    High flow nasal oxygenation
    Laryngeal microsurgery
    emergence cough
    Additional relevant MeSH terms:
    Cough

    Study Results

    No Results Posted as of Dec 2, 2022