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CompletedNCT04629911Updated Jan 5, 2022

High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients

An interventional study of THRIVE in Gastric Distention, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-05.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastric Distention
03

In context

Dilatation, Pathologic

260 studies on the registry are indexed under Dilatation, Pathologic; 43 are open to participants now.

This study's enrollment of 45 is below the median of 75 across 186 interventional studies indexed under Dilatation, Pathologic.

Browse Dilatation, Pathologic studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiology physical status classification I and II
  • Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • gastroesophageal reflux
  • gastric pathology
  • pregnancy
  • major cardiovascular, pulmonary, or cerebrovascular disease
  • severe obesity (body mass index>35 kg/m2)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    HFNO arm

    Patients will receive HFNO therapy during laryngomicrosurgery.

    Device: THRIVE

Interventions

  • DeviceTHRIVE

    Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.

    Also known as: Optiflow

06

What researchers measure

Primary outcomes

  1. change of gastric volume

    Ultrasound exam will measure the antral cross-sectional area of gastric antrum

    Time frame: before HFNO application (baseline), immediately after HFNO application

07

Study locations

1 site
  • Ajou University Hospital
    Suwon, Gyeongki-do 443-721, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04629911
Lead sponsor
Ajou University School of Medicine
Responsible party
Jong Yeop Kim (Professor, Ajou University School of Medicine) — Principal investigator
First posted
Nov 16, 2020
Start date
Nov 23, 2020
Primary completion
Aug 24, 2021
Completion
Aug 24, 2021
Last update
Jan 5, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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