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

Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559502
• Other study ID #: AJOUIRB-IV-2022-457
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Ajou University School of Medicine
• Contact: TaeKwang Kim, M.D.
• Phone: 82-031-219-5589
• Email: tk.kim[@]aumc.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cough

Intervention

Device:
• HFNO group
HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.
• ET group
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeongki-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with postoperative airway complications	post operative sore throat	from 1 hour after surgery to 24 hours after surgery