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The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)

NCT01437137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2013-06-04

No results posted yet for this study

Summary

Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel 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 c-LMA in infants.

Conditions

  • Airway Complication of Anaesthesia

Interventions

DEVICE

classic-laryngeal mask airway (c-LMA)

Insertion of c-LMA

DEVICE

i-gel™

Insertion of I-gel

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01437137 on ClinicalTrials.gov