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Clinical Trials/NCT04849520
NCT04849520
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country38 target enrollmentAugust 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Seoul National University Hospital
Enrollment
38
Locations
1
Primary Endpoint
Apnea success rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2021
End Date
March 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

MD, PhD, Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

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%

Secondary Outcomes

  • End-tidal carbon dioxide(After resuming of bag-mask ventilation, up to 30 seconds)
  • Pulse oximetry(From start of study to end of study, up to 20 min)
  • Apnea time(From start of apnea to drop of pulse oximetry to 92%, up to 520 seconds)
  • Time to pulse oximetry of 100 percent(After resuming of bag-mask ventilation, up to 300 seconds)
  • Minimal pulse oximetry(After resuming of bag-mask ventilation, up to 60 seconds)
  • Electrocardiogram(From start of study to end of study, up to 20 min)
  • Mean blood pressure(From start of study to end of study, up to 20 min)
  • Oxygen reserve index(From start of study to end of study, up to 20 min)
  • Transcutaneous carbon dioxide(From start of study to end of study, up to 20 min)
  • Heart rate(From start of study to end of study, up to 20 min)

Study Sites (1)

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