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 (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01314248
First received: March 10, 2011
Last updated: July 29, 2013
Last verified: July 2013
  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

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

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:

  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.
  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314248

Locations
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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, Attending, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01314248     History of Changes
Other Study ID Numbers: laryngeal mask airway & air Q
Study First Received: March 10, 2011
Last Updated: July 29, 2013
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 July 22, 2014