Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

Study Overview
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Brief Summary
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Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started. Oropharyngeal leak pressure, peak inspiratory pressure, success rate for insertion, ease for insertion, ease for gastric tube insertion and fiberoptic bronchoscopic views will be compared between two groups.

Official Title
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A Randomized Comparison of Ambu AuraGain (Original Name of Product) Laryngeal Mask Airway and I-gel in Children

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: AuraGain
* Device: I-gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children < 7 years old who scheduled for general anesthesia using supraglottic airway Exclusion Criteria: Children who require tracheal intubation Emergency operation without nil per os History of C-spine surgery or disease History of Esophageal disease or surgery

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AuraGain group<br>AuraGain is inserted for maintenance of general anesthesia. The size 1 is for children <5kg, size 2 for 5-10kg, size 2 for 10-20kg, and size 2.5 for 20-30kg. | Device: AuraGain<br>* After anesthetic induction, AuraGain is inserted in children<br>* Other names: Ambu AuraGain;|
| Experimental: I-gel group<br>I-gel is s inserted for maintenance of general anesthesia. The size 1 is for children weighted 2-5kg, size 2 for 5-12kg, size 2 for 10-25kg, and size 2.5 for 25-35kg. | Device: I-gel<br>* After anesthetic induction, I-gel is inserted in children<br>* Other names: I-gel supraglottic airway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate is fixed at 3 liter/min | 30 seconds after AuraGain or I-gel insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak inspiratory pressure | Peak airway pressure | through study completion, an average of 1 hour | 
| Success rate | Success rate of AuraGain or I-gel insertion | Within 5 minutes after anesthetic induction | 
| Ease of AuraGain or I-gel insertion | 1. No resistance 2. Moderate resistance 3. High resistance 4. Inability to pass | Within 5 minutes after anesthetic induction | 
| Ease of gastric tube insertion | 1. Easy 2. Difficult 3. Unable to pass | Within 5 minutes after anesthetic induction | 
| fiberoptic bronchoscopic veiw | 1. No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only glottis is visible | Within 10 minutes after anesthetic induction |