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Completed

NCT Number: NCT04849520

High Flow Nasal Cannula for Safe Apnea

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

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Key information

Conditions

Anesthesia, General Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Cannula

Device

Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min

Buccal oxygenation

Device

Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Pulse oximetry

    Time frame: From start of study to end of study, up to 20 min

    Pulse oximetry measured throughout the study

  8. Oxygen reserve index

    Time frame: From start of study to end of study, up to 20 min

    Oxygen reserve index measured throughout the study

  9. 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

  10. Heart rate

    Time frame: From start of study to end of study, up to 20 min

    Heart rate measured throughout the study

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Evidence-Based Healthcare Collaborating Agency

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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