NCT01437137

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	classic-laryngeal mask airway (c-LMA)	Insertion of c-LMA
DEVICE	i-gel™	Insertion of I-gel

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-09-20
• Last updated: 2013-06-04

Locations

1 site across 1 country: South Korea