The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients
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Purpose
The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.
| Condition | Intervention |
|---|---|
|
Children |
Device: each child will receive both the LMA and ILA |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | A Randomized Crossover Comparison Between the Air-Q Intubating Laryngeal Airway the Laryngeal Mask Airway-Unique in Children |
| Enrollment: | 50 |
| Study Start Date: | December 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| children weighing 10 to 15 kg |
Device: each child will receive both the LMA and ILA
each child will receive both the size 2 LMA and size 1.5 ILA
|
Detailed Description:
The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA 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. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards:
- We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached.
- We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.
Eligibility| Ages Eligible for Study: | 6 Months to 36 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Healthy children undergoing general anesthesia for their scheduled elective outpatient surgeries using a supraglottic airway device for airway maintenance.
Inclusion Criteria:
- Healthy children undergoing general anesthesia using a supraglottic airway device
- 6 months to 36 months of age
- 10 to 15 kilograms in weight
Exclusion Criteria:
- Active respiratory infection
- History of difficult mask ventilation
- Features or history of a difficult airway
- Gastrointestinal reflux disease
- Clinically significant pulmonary disease
Contacts and Locations| United States, Illinois | |
| Childrens Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| Principal Investigator: | Narasimhan Jagannathan, MD | Childrens Memorial Hospital |
More Information
No publications provided by Ann & Robert H Lurie Children's Hospital of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Narasimhan Jagannathan, MD, Childrens Memorial Hospital Department of Pediatric Anesthesia |
| ClinicalTrials.gov Identifier: | NCT01314248 History of Changes |
| Other Study ID Numbers: | laryngeal mask airway & air Q |
| Study First Received: | March 10, 2011 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
|
airway sealing pressure fiberoptic assessment ease and time for successful insertion incidence of gastric insufflation complications were also evaluated |
ClinicalTrials.gov processed this record on May 22, 2013