The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants

Not Applicable

• Conditions: Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway
• Interventions: Device: LMA Supreme; Device: I gel

• Registration Number: NCT01863316
• Lead Sponsor: Yonsei University

Brief Summary

Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1 and 1½. The pediatric i-gel and LMA Supreme are new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel and LMA Supreme in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and LMA Supreme in infants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-05-22
• Last Update Submitted: 2013-05-22
• Study First Posted: 2013-05-27
• Last Update Posted: 2013-05-27
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Infants (0-1 year of age) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

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Exclusion Criteria

1. Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2) LMA Supreme group	LMA Supreme	using supraglottic airway LMA Supreme
1) I gel group	I gel	using supraglottic airway I gel

Primary Outcome Measures

Name	Time	Method
airway leak pressure	within 5 min of insertion of each device	Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 30 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of