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High Flow Nasal Cannula for Safe Apnea

Primary Purpose

Anesthesia, General, Apnea

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High flow nasal cannula
Buccal oxygenation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia, General focused on measuring Oxygenation, High-flow nasal cannula

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2.

Exclusion Criteria:

  • Refusal of enrollment from one or more legal guardians of the patient
  • Plan of usage of supraglottic airway device as airway maintenance device
  • Presence of upper respiratory tract infection of lung disease
  • Premature infants younger than postconceptual age of 40 weeks
  • Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia
  • Other conditions that are considered inappropriate for the study

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High flow

Buccal

Arm Description

Application of high flow nasal cannula during apnea

Application of buccal oxygenation during apnea

Outcomes

Primary Outcome Measures

Apnea success rate
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry > 92%

Secondary Outcome Measures

Apnea time
Time elapsed from start of apnea to resume of bag-mask ventilation
End-tidal carbon dioxide
End-tidal carbon dioxide partial pressure of first resumed breath after apnea
Minimal pulse oximetry
Lowest value of pulse oximetry after resume of bag-mask ventilation
Time to pulse oximetry of 100 percent
Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value
Electrocardiogram
Appearance of any arrhythmia or prolonged QT interval measured throughout the study
Mean blood pressure
Mean non-invasive blood pressure measured throughout the study
Pulse oximetry
Pulse oximetry measured throughout the study
Oxygen reserve index
Oxygen reserve index measured throughout the study
Transcutaneous carbon dioxide
Transcutaneous carbon dioxide level measured throughout the study
Heart rate
Heart rate measured throughout the study

Full Information

First Posted
April 12, 2021
Last Updated
July 27, 2023
Sponsor
Seoul National University Hospital
Collaborators
National Evidence-Based Healthcare Collaborating Agency
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1. Study Identification

Unique Protocol Identification Number
NCT04849520
Brief Title
High Flow Nasal Cannula for Safe Apnea
Official Title
Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2021 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
National Evidence-Based Healthcare Collaborating Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.
Detailed Description
This is a prospective randomized controlled trial comparing two oxygenation methods for prolongation of apnea time in children aged 0 to 10 years old. This study measures time for the pulse oximetry drop from 100% to 92% after oxygenation with 100% oxygen, applying high flow nasal cannula or buccal oxygen insufflation via an oral Ring-Adair-Elwyn endotracheal tube connected to oxygen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General, Apnea
Keywords
Oxygenation, High-flow nasal cannula

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High flow
Arm Type
Experimental
Arm Description
Application of high flow nasal cannula during apnea
Arm Title
Buccal
Arm Type
Active Comparator
Arm Description
Application of buccal oxygenation during apnea
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Intervention Description
Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min
Intervention Type
Device
Intervention Name(s)
Buccal oxygenation
Intervention Description
Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min
Primary Outcome Measure Information:
Title
Apnea success rate
Description
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry > 92%
Time Frame
From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Secondary Outcome Measure Information:
Title
Apnea time
Description
Time elapsed from start of apnea to resume of bag-mask ventilation
Time Frame
From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Title
End-tidal carbon dioxide
Description
End-tidal carbon dioxide partial pressure of first resumed breath after apnea
Time Frame
After resuming of bag-mask ventilation, up to 30 seconds
Title
Minimal pulse oximetry
Description
Lowest value of pulse oximetry after resume of bag-mask ventilation
Time Frame
After resuming of bag-mask ventilation, up to 60 seconds
Title
Time to pulse oximetry of 100 percent
Description
Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value
Time Frame
After resuming of bag-mask ventilation, up to 300 seconds
Title
Electrocardiogram
Description
Appearance of any arrhythmia or prolonged QT interval measured throughout the study
Time Frame
From start of study to end of study, up to 20 min
Title
Mean blood pressure
Description
Mean non-invasive blood pressure measured throughout the study
Time Frame
From start of study to end of study, up to 20 min
Title
Pulse oximetry
Description
Pulse oximetry measured throughout the study
Time Frame
From start of study to end of study, up to 20 min
Title
Oxygen reserve index
Description
Oxygen reserve index measured throughout the study
Time Frame
From start of study to end of study, up to 20 min
Title
Transcutaneous carbon dioxide
Description
Transcutaneous carbon dioxide level measured throughout the study
Time Frame
From start of study to end of study, up to 20 min
Title
Heart rate
Description
Heart rate measured throughout the study
Time Frame
From start of study to end of study, up to 20 min

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children under 11 years old undergoing general anesthesia with American Society of Anesthesiologists Physical Status 1 or 2. Exclusion Criteria: Refusal of enrollment from one or more legal guardians of the patient Plan of usage of supraglottic airway device as airway maintenance device Presence of upper respiratory tract infection of lung disease Premature infants younger than postconceptual age of 40 weeks Anticipation of difficult bag-mask ventilation due to facial anomaly or micrognathia Other conditions that are considered inappropriate for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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High Flow Nasal Cannula for Safe Apnea

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