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

NCT01633073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2012-10-02

No results posted yet for this study

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.

Conditions

  • Laryngeal Masks in Children

Interventions

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.

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Narasimhan Jagannathan, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633073 on ClinicalTrials.gov