NCT01449656

A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.

Detailed description

The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Conditions

• Children

Interventions

Type	Name	Description
DEVICE	LMA Proseal: control device	LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization
DEVICE	LMA Supreme: comparison device	LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-10-10
• Last updated: 2011-12-12

Locations

1 site across 1 country: United States