High Flow Nasal Cannula for Safe Apnea

July 27, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth

This is a prospective randomized controlled trial comparing high flow nasal cannula and buccal oxygenation as method of oxygenation during apnea in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

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 Locations

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

No older than 10 years (Child)

Accepts Healthy Volunteers

No

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flow
Application of high flow nasal cannula during apnea
Device: High flow nasal cannula
Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min
Active Comparator: Buccal
Application of buccal oxygenation during apnea
Device: Buccal oxygenation
Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea success rate
Time Frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Proportion of patients that succeed in prolongation of apnea time while maintaining pulse oximetry > 92%
From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea time
Time Frame: From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
Time elapsed from start of apnea to resume of bag-mask ventilation
From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds
End-tidal carbon dioxide
Time Frame: After resuming of bag-mask ventilation, up to 30 seconds
End-tidal carbon dioxide partial pressure of first resumed breath after apnea
After resuming of bag-mask ventilation, up to 30 seconds
Minimal pulse oximetry
Time Frame: After resuming of bag-mask ventilation, up to 60 seconds
Lowest value of pulse oximetry after resume of bag-mask ventilation
After resuming of bag-mask ventilation, up to 60 seconds
Time to pulse oximetry of 100 percent
Time Frame: After resuming of bag-mask ventilation, up to 300 seconds
Time elapsed from resume of bag-mask ventilation to regain of 100 percent in the pulse oximetry value
After resuming of bag-mask ventilation, up to 300 seconds
Electrocardiogram
Time Frame: From start of study to end of study, up to 20 min
Appearance of any arrhythmia or prolonged QT interval measured throughout the study
From start of study to end of study, up to 20 min
Mean blood pressure
Time Frame: From start of study to end of study, up to 20 min
Mean non-invasive blood pressure measured throughout the study
From start of study to end of study, up to 20 min
Pulse oximetry
Time Frame: From start of study to end of study, up to 20 min
Pulse oximetry measured throughout the study
From start of study to end of study, up to 20 min
Oxygen reserve index
Time Frame: From start of study to end of study, up to 20 min
Oxygen reserve index measured throughout the study
From start of study to end of study, up to 20 min
Transcutaneous carbon dioxide
Time Frame: From start of study to end of study, up to 20 min
Transcutaneous carbon dioxide level measured throughout the study
From start of study to end of study, up to 20 min
Heart rate
Time Frame: From start of study to end of study, up to 20 min
Heart rate measured throughout the study
From start of study to end of study, up to 20 min

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

National Evidence-Based Healthcare Collaborating Agency

Investigators

  • Principal Investigator: Jin-Tae Kim, M.D., Ph.D., Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 12, 2021

Primary Completion (Actual)

March 21, 2023

Study Completion (Actual)

March 21, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2102-149-1200

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

Yes

product manufactured in and exported from the U.S.

Yes

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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