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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Children's Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01385761
First received: June 28, 2011
Last updated: March 9, 2012
Last verified: March 2012

June 28, 2011
March 9, 2012
June 2011
March 2012   (final data collection date for primary outcome measure)
Oropharyngeal leak pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01385761 on ClinicalTrials.gov Archive Site
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LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
3 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01385761
IRB#2011-14642
No
Narasimhan Jagannathan, Children's Memorial Hospital
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
March 2012

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