High-flow Nasal Oxygenation for Open Mouth

Study Overview
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Brief Summary
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This study aims to evaluate the effect of high-flow nasal oxygenation on safe apnea time for children undergoing general anesthesia, with their mouth open.

Detailed Description
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Oxygenation via high-flow nasal cannula is gaining popularity in various clinical settings. It is known to increase apnea time for apneic patients including children. However, high-flow nasal cannula is known to be ineffective when the patient's mouth is kept open. When trying to intubate the patient during induction of anesthesia, the patient should be apneic with administration of neuromuscular blocking agent, and the mouth should be open for introduction of laryngoscope. We designed a prospective randomized controlled study to evaluate the effect of high-flow nasal oxygenation in the aforementioned setting for trying to intubate the patient.

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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Anesthesia, General, Apnea

Intervention / Treatment
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* Device: Apnea with high-flow nasal cannula
* Other: Apnea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children younger than 11 years old scheduled to undergo surgery under general anesthesia, with American Society of Anesthesiologists Physical Status 1 or 2. Exclusion Criteria: Refusal to enrollment from one or more of legal guardians of the patient Children who are planned to use supraglottic airway device Children with upper respiratory tract infection or pulmonary interstitial disease Preterm babies under 40 weeks of postconceptual age Children who are expected to have difficult airway for bag-mask ventilation

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: Randomized, controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow<br>Apply high-flow nasal oxygenation during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired. | Device: Apnea with high-flow nasal cannula<br>* Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min<br>* Other names: Airvo 2;|
| Active Comparator: Control<br>Apply nothing during apnea with open mouth after adequate preoxygenation. Resume bag-mask ventilation when pulse oximetry drops to 92% or pre-set apnea time has expired. | Other: Apnea<br>* Apnea without any application of oxygenation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea time | Time required for pulse oximetry to drop to 92% after start of apnea | Elapsed time starting from discontinuation of oxygen to the time point that pulse oximetry first reaches 92% (not to exceed 520 seconds) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal carbon dioxide | End-tidal carbon dioxide partial pressure during anesthesia | Procedure (From induction of anesthesia to end of anesthesia) | 
| Pulse oximetry | Pulse oximetry during anesthesia | Procedure (From induction of anesthesia to end of anesthesia) | 
| Non-invasive blood pressure | Non-invasive blood pressure measured from forearm or leg | Procedure (From induction of anesthesia to end of anesthesia) | 
| Oxygen reserve index | Oxygen reserve index measured from finger or toe | Procedure (From induction of anesthesia to end of anesthesia) | 
| Time to 100% | Elapsed time from re-start of bag-mask ventilation to recovery of pulse oximetry of 100% after apnea | Elapsed time starting from re-start of bag-mask ventilation at the end of apnea period to the time point that pulse oximetry first reaches 100% (estimated less than 2 minutes) | 
| Minimum value of pulse oximetry | Minimum value of pulse oximetry after re-start of bag-mask ventilation after apnea | Procedure (From induction of anesthesia to end of anesthesia) | 
| 1st value of end-tidal carbon dioxide | First measured value of end-tidal carbon dioxide partial pressure after re-start of bag-mask ventilation after apnea | At expiration of the first manual ventilation after the end of the apnea period (less than 520 seconds after start of apnea period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-flow nasal cannula, Preoxygenation, Apnea time, General anesthesia