Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01437137
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2011-09-14
Brief Title:
The Clinical Efficacy of Recently Developed Supraglottic Airway Device I-gel in Neonates and Infants Comparison With Classic-laryngeal Mask Airway c-LMA
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None