High Flow Nasal Oxygenation vs Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
Comparison of High Flow Nasal Oxygenation Versus Endotracheal Intubation on Recovery Profiles in Laryngeal Microsurgery
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedDecember 27, 2023
December 1, 2023
1.6 years
September 26, 2022
December 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.)
From end of surgery to extubation
Secondary Outcomes (1)
Number of Participants with postoperative airway complications
from 1 hour after surgery to 24 hours after surgery
Study Arms (2)
HFNO group
EXPERIMENTALPatients will receive HFNO therapy during laryngomicrosurgery.
ET group
ACTIVE COMPARATOREndotracheal intubation was performed for general anesthesia
Interventions
HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Eligibility Criteria
You may qualify if:
- Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia for laryngeal microsurgery
You may not qualify if:
- Patients with major cardiovascular, pulmonary, and cerebrovascular disease
- Laser laryngeal surgery
- Morbid obesity (BMI\>35 kg/m2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou University Hospital
Suwon, Gyeongki-do, 443-721, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JongYeop Kim, M.D.,Ph.D.
Ajou University School of Medicine
Central Study Contacts
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
- Professor
Study Record Dates
First Submitted
September 26, 2022
First Posted
September 29, 2022
Study Start
November 15, 2022
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
December 27, 2023
Record last verified: 2023-12