NCT05571982

Brief Summary

The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

Study Start

First participant enrolled

October 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2025

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

October 6, 2022

Last Update Submit

June 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • End-tidal O2

    End-tidal O2 will be monitored continuously before anesthetic induction.

    for 10 minutes before anesthetic induction. At Day 0.

Study Arms (2)

Tidal volume breathing technique

EXPERIMENTAL

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

Vital capacity breathing technique

ACTIVE COMPARATOR

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

Interventions

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.

Tidal volume 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.

Vital capacity breathing technique

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Study Officials

  • Hyun Joo Kim

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 7, 2022

Study Start

October 1, 2022

Primary Completion

September 22, 2025

Study Completion

September 22, 2025

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations