Back to resultsComparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
Primary Purpose
Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tidal volume breathing technique
Vital capacity breathing technique
Sponsored by
About this trial
This is an interventional prevention trial for Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
Eligibility Criteria
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
Sites / Locations
- Yonsei University Health System, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tidal volume breathing technique
Vital capacity breathing technique
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Oxygen reserve index
End-tidal O2 will be monitored continuously before anesthetic induction.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05571982
Brief Title
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
Official Title
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the preoxygenation efficacy of tidal volume breathing and vital capacity breathing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Patients 20 Years of Age or Older Who Are Planning to Undergo Surgery Under General Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tidal volume breathing technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Vital capacity breathing technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tidal volume breathing technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vital capacity breathing technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen reserve index
Description
End-tidal O2 will be monitored continuously before anesthetic induction.
Time Frame
for 10 minutes before anesthetic induction. At Day 0.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Joo Kim
Phone
02-2224-1389
Email
jjollong@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Kim
Phone
02-2224-1389
Email
jjollong@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Efficacy of Tidal Volume Breathing and Vital Capacity Breathing During High-flow Nasal Oxygen
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