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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal Mask airway (LMA) | children weighing 20 to 30 kg |
| |
| Intubating Laryngeal Airway (ILA-SP) | Children weighing 20-30 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Mask Airway | Device | Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal leak pressure | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device
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| Name | Affiliation | Role |
|---|---|---|
| Narasimhan Jagannathan, MD | Childrens Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens Memorial Hospital | Chicago | Illinois | 60618 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21518103 | Background | Jagannathan N, Sohn LE, Mankoo R, Langen KE, Roth AG, Hall SC. Prospective evaluation of the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2011 Jun;21(6):673-80. doi: 10.1111/j.1460-9592.2011.03576.x. | |
| 15298876 | Background | Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6. |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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|
| air-QTM Intubating Laryngeal Airway | Device | Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance. |
|
|
| 19572845 | Background | White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x. |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |