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
  Purpose

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 Intervention
Children
Device: Laryngeal Mask Airway
Device: air-QTM Intubating Laryngeal Airway

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Oropharyngeal leak pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA

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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
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: NCT01385761

Locations
United States, Illinois
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
  More Information

Publications:
Responsible Party: Narasimhan Jagannathan, primary investigator, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT01385761     History of Changes
Other Study ID Numbers: IRB#2011-14642
Study First Received: June 28, 2011
Last Updated: March 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Supraglottic airway devices

ClinicalTrials.gov processed this record on September 16, 2014