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

Primary Purpose

Cough

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HFNO group
ET group
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring High flow nasal oxygenation, Laryngeal microsurgery, emergence cough

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HFNO group

ET group

Arm Description

Patients will receive HFNO therapy during laryngomicrosurgery.

Endotracheal intubation was performed for general anesthesia

Outcomes

Primary Outcome Measures

Grade of Emergence cough during periextubation period
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

Number of Participants with postoperative airway complications
post operative sore throat

Full Information

First Posted
September 26, 2022
Last Updated
November 30, 2022
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05559502
Brief Title
High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
Official Title
Comparison of High Flow Nasal Oxygenation Versus Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
High flow nasal oxygenation, Laryngeal microsurgery, emergence cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HFNO group
Arm Type
Experimental
Arm Description
Patients will receive HFNO therapy during laryngomicrosurgery.
Arm Title
ET group
Arm Type
Active Comparator
Arm Description
Endotracheal intubation was performed for general anesthesia
Intervention Type
Device
Intervention Name(s)
HFNO group
Other Intervention Name(s)
Optiflow
Intervention Description
HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
Intervention Type
Device
Intervention Name(s)
ET group
Other Intervention Name(s)
Portex, Smiths Medical International Ltd., South East England, United Kingdom
Intervention Description
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Primary Outcome Measure Information:
Title
Grade of Emergence cough during periextubation period
Description
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.)
Time Frame
From end of surgery to extubation
Secondary Outcome Measure Information:
Title
Number of Participants with postoperative airway complications
Description
post operative sore throat
Time Frame
from 1 hour after surgery to 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TaeKwang Kim, M.D.
Phone
82-031-219-5589
Email
tk.kim@aumc.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
JongYeop Kim, M.D.,Ph.D.
Phone
82-031-219-5574
Email
kjyeop@ajou.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongYeop Kim, M.D.,Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Tae Kwang Kim, M.D
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim, M.D., Ph.D.

12. IPD Sharing Statement

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

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