Comparison of AuraGain With I-gel for Pediatric Patients

Study Overview
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Brief Summary
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Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist. The outcome measures are recorded and analysed.

Official Title
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A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young 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: ASA physical status: 1-3 age: from 6 months to 6 year body weight: 5-20kg patients undergoing upper/lower extremity surgery at supine position Exclusion Criteria: patients who do not want to participate in this study patients with known difficult airway including congenital facial anomaly or history of difficult airway management patients with aspiration risk (gastrointestinal stenosis or stricture) patients with symptom of upper respiratory infection on the day of surgery patients scheduled for day surgery patients judged as not eligible by researchers for other reasons

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AuraGain<br>After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg. | Device: AuraGain<br>* After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.<br>|
| Active Comparator: I-gel<br>After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg. | Device: I-gel<br>* After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| requirement of additional airway maneuver | including adjustment of head/neck position or insertion depth and taping of the device | during placement/maintenance of the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time |  | during placement of the device | 
| success rate |  | during placement of the device | 
| ease of gastric tube insertion |  | within 10 minutes after device insertion | 
| adverse effect at operating room | aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device | during anesthesia | 
| postoperative adverse effect | sore throat, hoarseness, airway obstruction | within postoperative 24 hours | 
| fiberoptic view of glottis | Brimacombe score | within 10 minutes after device insertion | 
| oropharyngeal leak pressure |  | at 1 minute after device insertion, at 10 minutes after device insertion |