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

Not Applicable

Completed

• Conditions: Airway Complication of Anaesthesia
• Interventions: Device: i-gel™; Device: classic-laryngeal mask airway (c-LMA)

• Registration Number: NCT01437137
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-20
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

• patients with an abnormal airway
• with reactive airway disease
• with gastroesophageal reflux disease
• with chronic respiratory disease
• has a history of an upper respiratory tract infection in the preceding 6-week period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-gel group	i-gel™	-
LMA group	classic-laryngeal mask airway (c-LMA)	-

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 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of