Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen

October 6, 2022 updated by: Yonsei University
The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

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 Contact

Study Locations

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

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 20 years of age or older who are planning to undergo surgery under general anesthesia

Exclusion Criteria:

-basal skull fracture, 2번 - facial anomaly, 3번 - consciousness disorder, 4번 - Risk of aspiration

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tidal volume breathing technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Tidal volume breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.
Procedure: Tidal volume breathing technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Tidal volume breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.
Active Comparator: Vital capacity breathing technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Vital capacity breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.
Procedure: Vital capacity breathing technique
High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system before anesthetic induction. Vital capacity breathing will be applied. Pulse oximetry, end-tidal O2, and oxygen reserve index will be monitored continuously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen reserve index
Time Frame: for 10 minutes before anesthetic induction. At Day 0.
End-tidal O2 will be monitored continuously before anesthetic induction.
for 10 minutes before anesthetic induction. At Day 0.

Collaborators and Investigators

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

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyun Joo Kim, Severance Hospital

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-1017

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

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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