Clinical Trials Directory

Trials / Completed

CompletedNCT01409785

A Comparison of the LMA Unique and LMA Supreme in Children

A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children

Status
Completed
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
Sex
All
Age
6 Months – 6 Years
Healthy volunteers
Accepted

Summary

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.

Detailed description

The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal. The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.

Conditions

Timeline

Start date
2011-08-01
Primary completion
2011-09-01
Completion
2011-09-01
First posted
2011-08-04
Last updated
2011-10-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01409785. Inclusion in this directory is not an endorsement.