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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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT04291339
Collaborator
(none)
198
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
97.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: High-flow nasal oxygen technique
  • Procedure: Mask ventilation technique
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Nov 11, 2020
Actual Primary Completion Date :
Jan 12, 2021
Actual Study Completion Date :
Jan 12, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Peak oxygen reserve index value [for 10 minutes during anesthetic induction. At Day 0.]

    Oxygen reserve index will be monitored continuously during anesthetic induction.

Secondary Outcome Measures

  1. The time to achieve the peak oxygen reserve index value [for 10 minutes during anesthetic induction. At Day 0.]

    Oxygen reserve index will be monitored continuously during anesthetic induction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04291339
Other Study ID Numbers:
  • 4-2019-1336
First Posted:
Mar 2, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 1, 2021