Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-29 @ 3:43 PM
Study NCT ID:
NCT01653795
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2012-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children
Status:
COMPLETED
Status Verified Date:
2012-11
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:
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.
Detailed Description:
The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.
Study Oversight
Has Oversight DMC:
True
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?: