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

NCT01437137 | Completed

• 1 other identifier: 1-2011-0052
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Complication of Anaesthesia

Keywords

elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Outcome Measures

Primary Outcomes (1)

• airway leak pressure

  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.

  within 5 min of insertion of each device

Study Arms (2)

LMA group

ACTIVE COMPARATOR

Device: classic-laryngeal mask airway (c-LMA)

I-gel group

EXPERIMENTAL

Device: i-gel™

Interventions

classic-laryngeal mask airway (c-LMA) DEVICE

Insertion of c-LMA

LMA group

i-gel™ DEVICE

Insertion of I-gel

I-gel group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• Beylacq L, Bordes M, Semjen F, Cros AM. The I-gel, a single-use supraglottic airway device with a non-inflatable cuff and an esophageal vent: an observational study in children. Acta Anaesthesiol Scand. 2009 Mar;53(3):376-9. doi: 10.1111/j.1399-6576.2008.01869.x.

  PMID: 19243322 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 20, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

KR (1)