High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

Gastric Distention Clinical Trial

Official title:

The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629911
• Other study ID #: MED-DE1-20-424
• Status: Completed
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: August 24, 2021

Study information

• Verified date: January 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• 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.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Description:

HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.

In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology physical status classification I and II

• Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

• gastroesophageal reflux

• gastric pathology

• pregnancy

• major cardiovascular, pulmonary, or cerebrovascular disease

• severe obesity (body mass index>35 kg/m2)

Related Conditions & MeSH terms

• Gastric Distention

Intervention

Device:
• THRIVE
Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.

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	change of gastric volume	Ultrasound exam will measure the antral cross-sectional area of gastric antrum	before HFNO application (baseline), immediately after HFNO application