Clinical Trials Directory

Trials / Completed

CompletedNCT01385761

LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway 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
3 Years – 9 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

Detailed description

The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Conditions

Interventions

TypeNameDescription
DEVICELaryngeal Mask AirwayEach child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
DEVICEair-QTM Intubating Laryngeal AirwayEach child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Timeline

Start date
2011-06-01
Primary completion
2012-03-01
Completion
2012-03-01
First posted
2011-06-30
Last updated
2012-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01385761. Inclusion in this directory is not an endorsement.