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
| Type | Name | Description |
|---|---|---|
| DEVICE | Laryngeal Mask Airway | Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance. |
| DEVICE | air-QTM Intubating Laryngeal Airway | Each 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.