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

March 9, 2012 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60618
        • Childrens Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oropharyngeal leak pressure
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

March 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 29, 2011

First Posted (ESTIMATE)

June 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB#2011-14642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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