Comparison of AuraGain With I-gel for Pediatric Patients

Asan Medical Center68 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

General Anesthesia

Interventions

AuraGainDEVICE

After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.

I-gelDEVICE

After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

requirement of additional airway maneuver

including adjustment of head/neck position or insertion depth and taping of the device

Time frame: during placement/maintenance of the device

Secondary Outcomes

insertion time

Time frame: during placement of the device

success rate

Time frame: during placement of the device

ease of gastric tube insertion

Time frame: 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

Time frame: during anesthesia

postoperative adverse effect

sore throat, hoarseness, airway obstruction

Time frame: within postoperative 24 hours

fiberoptic view of glottis

Brimacombe score

Time frame: within 10 minutes after device insertion

oropharyngeal leak pressure

Time frame: at 1 minute after device insertion, at 10 minutes after device insertion

Data from ClinicalTrials.gov

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