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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01437137
First received: September 14, 2011
Last updated: June 1, 2013
Last verified: June 2013

September 14, 2011
June 1, 2013
September 2011
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01437137 on ClinicalTrials.gov Archive Site
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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)
Not Provided

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Airway Complication of Anaesthesia
  • Device: classic-laryngeal mask airway (c-LMA)
    Insertion of c-LMA
  • Device: i-gel™
    Insertion of I-gel
  • Active Comparator: LMA group
    Intervention: Device: classic-laryngeal mask airway (c-LMA)
  • Experimental: I-gel group
    Intervention: Device: i-gel™
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01437137
1-2011-0052
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP