The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01314248
First received: March 10, 2011
Last updated: April 5, 2011
Last verified: April 2011

March 10, 2011
April 5, 2011
December 2010
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01314248 on ClinicalTrials.gov Archive Site
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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

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.

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:

  1. 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.
  2. 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.
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Probability Sample

Healthy children undergoing general anesthesia for their scheduled elective outpatient surgeries using a supraglottic airway device for airway maintenance.

Children
Device: each child will receive both the LMA and ILA
each child will receive both the size 2 LMA and size 1.5 ILA
children weighing 10 to 15 kg
Intervention: Device: each child will receive both the LMA and ILA
Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique™ and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. Epub 2011 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01314248
laryngeal mask airway & air Q
Yes
Narasimhan Jagannathan, MD, Childrens Memorial Hospital Department of Pediatric Anesthesia
Ann & Robert H Lurie Children's Hospital of Chicago
Not Provided
Principal Investigator: Narasimhan Jagannathan, MD Childrens Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP