Comparison of AuraGain With I-gel for Pediatric Patients

Asan Medical Center

Status: Completed

Conditions: General Anesthesia

Treatments: Device: I-gel; Device: AuraGain

Study type: Interventional

Funder types: Other

Identifiers

NCT03294226

S2017-1229

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

AuraGain

Experimental group

Description:

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.

Treatment:

Device: AuraGain

I-gel

Active Comparator group

Description:

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.

Treatment:

Device: I-gel