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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)

Yonsei University logo

Yonsei University

Status

Completed

Conditions

Airway Complication of Anaesthesia

Treatments

Device: i-gel™
Device: classic-laryngeal mask airway (c-LMA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01437137
1-2011-0052

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

Under 1 year old

Volunteers

No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

LMA group
Active Comparator group
Treatment:
Device: classic-laryngeal mask airway (c-LMA)
I-gel group
Experimental group
Treatment:
Device: i-gel™

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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