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

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01385761
Collaborator
(none)
60
Enrollment
1
Location
9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Laryngeal Mask Airway
  • Device: air-QTM Intubating Laryngeal Airway

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Laryngeal Mask airway (LMA)

children weighing 20 to 30 kg

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 Names:
  • Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA)

    		•
    Intubating Laryngeal Airway (ILA-SP)

    Children weighing 20-30 kg

    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 Names:
  • air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Oropharyngeal leak pressure [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Childrens Memorial Hospital Chicago Illinois United States 60618

    Sponsors and Collaborators

    • Ann & Robert H Lurie Children's Hospital of Chicago

    Investigators

    • Principal Investigator: Narasimhan Jagannathan, MD, Childrens Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Narasimhan Jagannathan, primary investigator, Ann & Robert H Lurie Children's Hospital of Chicago
    ClinicalTrials.gov Identifier:
    NCT01385761
    Other Study ID Numbers:
    • IRB#2011-14642
    First Posted:
    Jun 30, 2011
    Last Update Posted:
    Mar 13, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Narasimhan Jagannathan, primary investigator, Ann & Robert H Lurie Children's Hospital of Chicago
    Supraglottic airway devices

    Study Results

    No Results Posted as of Mar 13, 2012