NCT04629911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

November 10, 2020

Last Update Submit

January 3, 2022

Conditions

Gastric Distention

Outcome Measures

Primary Outcomes (1)

  • change of gastric volume

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

    before HFNO application (baseline), immediately after HFNO application

Study Arms (1)

HFNO arm

EXPERIMENTAL

Patients will receive HFNO therapy during laryngomicrosurgery.

Device: THRIVE

Interventions

THRIVEDEVICE

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

Also known as: Optiflow
HFNO arm

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 16, 2020

Study Start

November 23, 2020

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

KR(1)