High-flow Nasal Cannula for Pediatric Anesthetic Induction

Study Overview
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Brief Summary
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Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation. The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 84 patients undergoing elective surgery aged <=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.

Official Title
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The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial

Conditions
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Oxygen Deficiency

Intervention / Treatment
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* Procedure: high flow nasal oxygen
* Procedure: face mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants undergoing general anesthesia with endotracheal intubation. Exclusion Criteria: infants who diagnosed as cardiorespiratory problem preoperatively.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high flow nasal oxygen<br> | Procedure: high flow nasal oxygen<br>* In the intervention group, pre-oxygenation was provided using HFNO via Optiflow THRIVE™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) until SpO2 on pulse oximetry was > 95% and for at least 3 min. A flow of 0.5 l/kg/min-1 was used until induction agents had been administered, and then increased to 2 l/kg/min-1. Nasal oxygenation was continued without ventilation of the lungs while waiting for neuromuscular blockade, and during placing, replacing or repositioning the airway. Anaesthetists were free to carry out bag-mask ventilation of the lungs if they considered this necessary to maintain safe oxygen saturations. After securing the airway, the patient was connected to a circle circuit primed with 100% oxygen and the FIO2 was continued at 100% for a period of at least five more minutes. Relevant times were recorded, including start of pre-oxygenation and start of induction of anaesthesia.<br>|
| Active Comparator: face mask<br> | Procedure: face mask<br>* In the control group, pre-oxygenation was provided using 100% oxygen via a sealed facemask and a circle-absorber anaesthetic circuit primed with 100% oxygen by installing a ventilation bag to the mouthpiece filter and ventilating the circuit with 100% oxygen. Anaesthetists were free to carry out bag-mask ventilation of the lungs once induction medications had been administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of oxygen desaturation <95% |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of oxygen desaturation <90% |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| the lowest oxygen saturation |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| the changes in oxygen reserve index |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| ETCO2 in first breath after intubation |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| ETO2 in first breath after intubation |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Number of intubation attempts |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Intubation times | time required to securing the airway. | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Occurrence of rescue bag mask ventilation |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. | 
| Occurrence of gastric insufflation |  | from induction of anesthesia to 1 minutes after intubation, about 10 minutes. |