High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

Not Applicable

Completed

• Conditions: Gastric Distention
• Interventions: Device: THRIVE

• Registration Number: NCT04629911
• Lead Sponsor: Ajou University School of Medicine

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.

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-10
• Study First Posted: 2020-11-16
• Study Start: 2020-11-23
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFNO arm	THRIVE	Patients will receive HFNO therapy during laryngomicrosurgery.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Gyeongki-do, Korea, Republic of