NCT01633073

A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 3 Months – 11 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

Detailed description

The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

Conditions

• Laryngeal Masks in Children

Interventions

Type	Name	Description
DEVICE	LMA Supreme: control device	LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
DEVICE	i-gel: comparison device	i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-07-04
• Last updated: 2012-10-02

Locations

1 site across 1 country: United States