- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01314248
The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients
A Randomized Crossover Comparison Between the Air-Q Intubating Laryngeal Airway the Laryngeal Mask Airway-Unique in Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children weighing 10 to 15 kg
|
each child will receive both the size 2 LMA and size 1.5 ILA
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- laryngeal mask airway & air Q
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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