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The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique.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.