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Clinical Trials/NCT05559502
NCT05559502CompletedNot Applicable

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

Ajou University School of Medicine3 sites in 2 countries52 target enrollmentStarted: November 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
52
Locations
3
Primary Endpoint
Grade of Emergence cough during periextubation period

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 80 Years (Adult, Older Adult)
Sex
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)

Arms & Interventions

HFNO group

Experimental

Patients will receive HFNO therapy during laryngomicrosurgery.

Intervention: HFNO group (Device)

ET group

Active Comparator

Endotracheal intubation was performed for general anesthesia

Intervention: ET group (Device)

Outcomes

Primary Outcomes

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.)

Secondary Outcomes

  • Number of Participants with postoperative airway complications(from 1 hour after surgery to 24 hours after surgery)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jong Yeop Kim

Professor

Ajou University School of Medicine

Study Sites (3)

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