Text Size

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

This study is currently recruiting participants.
Verified January 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Jeong-Rim LEE, Yonsei University
ClinicalTrials.gov Identifier:
NCT01437137
First received: September 14, 2011
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention
Airway Complication of Anaesthesia
 Device: classic-laryngeal mask airway (c-LMA)
Device: i-gel™

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • airway leak pressure [ Time Frame: within 5 min of insertion of each device ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 54
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437137

Contacts
Contact: Jeong-Rim Lee, MD, PhD 82-2-2227-3840 MANYA@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jeong Rim Lee, MD, PhD     82-2-2227-3840     MANYA@yuhs.ac    
Principal Investigator: Jeong Rim Lee, MD, PhD            
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Jeong-Rim LEE, assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01437137     History of Changes
Other Study ID Numbers: 1-2011-0052
Study First Received: September 14, 2011
Last Updated: January 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on May 23, 2013