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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437137
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Airway Complication of Anaesthesia Device: classic-laryngeal mask airway (c-LMA) Device: i-gel™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : September 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Active Comparator: LMA group Device: classic-laryngeal mask airway (c-LMA)
Insertion of c-LMA

Experimental: I-gel group Device: i-gel™
Insertion of I-gel

Primary Outcome Measures :
  1. airway leak pressure [ Time Frame: 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.

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437137

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT01437137     History of Changes
Other Study ID Numbers: 1-2011-0052
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Yonsei University:
elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway