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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

Conditions
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Children

Intervention / Treatment
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* Device: Laryngeal Mask Airway
* Device: air-QTM Intubating Laryngeal Airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing general anesthesia using a supraglottic airway device 3 to 9 years of age 20 to 30 kilograms in weight Exclusion Criteria: History of a difficult airway Active gastrointestinal reflux Active upper respiratory tract infection

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laryngeal Mask airway (LMA)<br>children weighing 20 to 30 kg | Device: Laryngeal Mask Airway<br>* Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.<br>* Other names: Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA);|
| Intubating Laryngeal Airway (ILA-SP)<br>Children weighing 20-30 kg | Device: air-QTM Intubating Laryngeal Airway<br>* Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.<br>* Other names: air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic airway devices