Comparison of the Efficacy of High-flow Nasal Oxygen Therapy and Facial Mask Ventilation on the Increase of the Oxygen Reserve Index During Anesthetic Induction

May 28, 2021 updated by: Yonsei University
The purpose of this study is to compare the ability of oxygenation with high-flow nasal oxygen therapy and mask ventilation technique for induction of anesthesia in adult patients who are planning to undergo surgery under general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients aged over 19 years who are scheduled for sleep endoscopy

Exclusion Criteria:

  • basal skull fracture
  • facial anomaly
  • consciousness disorder
  • Risk of aspiration
  • necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flow nasal oxygen technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
Procedure: High-flow nasal oxygen technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
Active Comparator: Mask ventilation technique
Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
Procedure: Mask ventilation technique
Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen reserve index value
Time Frame: for 10 minutes during anesthetic induction. At Day 0.
Oxygen reserve index will be monitored continuously during anesthetic induction.
for 10 minutes during anesthetic induction. At Day 0.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to achieve the peak oxygen reserve index value
Time Frame: for 10 minutes during anesthetic induction. At Day 0.
Oxygen reserve index will be monitored continuously during anesthetic induction.
for 10 minutes during anesthetic induction. At Day 0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2019-1336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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