Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: AuraGain; Device: I-gel

• Registration Number: NCT03118245
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-09
• Study First Submitted QC: 2017-04-14
• Study First Posted: 2017-04-18
• Study Start: 2017-06-12
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AuraGain group	AuraGain	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.
I-gel group	I-gel	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.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	30 seconds after AuraGain or I-gel insertion	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of