Comparison of AuraGain With I-gel for Pediatric Patients

Not Applicable

Completed

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

• Registration Number: NCT03294226
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Study Start: 2017-09-25
• Study First Posted: 2017-09-26
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
requirement of additional airway maneuver	during placement/maintenance of the device	including adjustment of head/neck position or insertion depth and taping of the device

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of