High Flow Nasal Cannula for Safe Apnea

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Apnea, Anesthesia, General

Intervention / Treatment
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* Device: High flow nasal cannula
* Device: Buccal oxygenation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled trial
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea success rate | 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 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 | 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 | 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 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 | 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 | Mean non-invasive blood pressure measured throughout the study | From start of study to end of study, up to 20 min | 
| Pulse oximetry | Pulse oximetry measured throughout the study | From start of study to end of study, up to 20 min | 
| Oxygen reserve index | Oxygen reserve index measured throughout the study | From start of study to end of study, up to 20 min | 
| Transcutaneous carbon dioxide | Transcutaneous carbon dioxide level measured throughout the study | From start of study to end of study, up to 20 min | 
| Heart rate | Heart rate measured throughout the study | From start of study to end of study, up to 20 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygenation, High-flow nasal cannula