Ambu AuraGain Laryngeal Mask Airway and I-gel in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03118245

Enrollment

Registered

2017-04-18

Start date

2017-06-12

Completion date

2018-05-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

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.

Interventions

DEVICEAuraGain

After anesthetic induction, AuraGain is inserted in children

DEVICEI-gel

After anesthetic induction, I-gel is inserted in children

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Peak inspiratory pressure	through study completion, an average of 1 hour	Peak airway pressure
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
Ease of gastric tube insertion	Within 5 minutes after anesthetic induction	1\. Easy 2. Difficult 3. Unable 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026