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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University College of Medicine
    • Contact: Jeong-Rim LEE, MD; Phone Number: 02-2227-3840; Email: MANYA@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1) I gel group; using supraglottic airway I gel	Device: I gel
Active Comparator: 2) LMA Supreme group; using supraglottic airway LMA Supreme	Device: LMA Supreme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway leak pressure	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.	within 5 min of insertion of each device

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 27, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 22, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: LMA Supreme, i-gel, supraglottic airway
• Other Study ID Numbers: 1-2013-0023