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High Flow Nasal Cannula for Safe Apnea

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04849520
Collaborator
National Evidence-Based Healthcare Collaborating Agency (Other)
38
Enrollment
1
Location
2
Arms
18.6
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High flow nasal cannula
  • Device: Buccal oxygenation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomized controlled trialProspective randomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of High-flow Nasal Oxygenation on Safe Apnea Time in Children With Open Mouth
Actual Study Start Date :
Aug 12, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Apnea success rate [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%

Secondary Outcome Measures

  1. Apnea time [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

  2. End-tidal carbon dioxide [After resuming of bag-mask ventilation, up to 30 seconds]

    End-tidal carbon dioxide partial pressure of first resumed breath after apnea

  3. Minimal pulse oximetry [After resuming of bag-mask ventilation, up to 60 seconds]

    Lowest value of pulse oximetry after resume of bag-mask ventilation

  4. Time to pulse oximetry of 100 percent [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

  5. Electrocardiogram [From start of study to end of study, up to 20 min]

    Appearance of any arrhythmia or prolonged QT interval measured throughout the study

  6. Mean blood pressure [From start of study to end of study, up to 20 min]

    Mean non-invasive blood pressure measured throughout the study

  7. Pulse oximetry [From start of study to end of study, up to 20 min]

    Pulse oximetry measured throughout the study

  8. Oxygen reserve index [From start of study to end of study, up to 20 min]

    Oxygen reserve index measured throughout the study

  9. Transcutaneous carbon dioxide [From start of study to end of study, up to 20 min]

    Transcutaneous carbon dioxide level measured throughout the study

  10. Heart rate [From start of study to end of study, up to 20 min]

    Heart rate measured throughout the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital
  • National Evidence-Based Healthcare Collaborating Agency

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jin-Tae Kim, MD, PhD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT04849520
Other Study ID Numbers:
  • 2102-149-1200
First Posted:
Apr 19, 2021
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
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:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Jin-Tae Kim, MD, PhD, Professor, Seoul National University Hospital
Oxygenation
High-flow nasal cannula
Additional relevant MeSH terms:
Apnea

Study Results

No Results Posted as of Feb 25, 2022