Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristopher Schroeder, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01328405
First received: March 29, 2011
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

Introduction:

The air-QⓇ Intubating Laryngeal Airway (ILA) is a newer supraglottic airway. It is approved for use as a primary airway and as an aid for intubation in situations of anticipated or unanticipated difficult airways. A unique feature of this device as compared to other airways on the market is the size of the inner diameter (ID) and length of its airway tube. Direct placement of tracheal tubes > 7.5 mm ID through the airway tube is possible.

The ProSealTM LMA is considered the gold standard for supraglottic devices with respect to airway seal pressure. On average, it is reported to be approximately 28 cmH2O. This is significantly higher than that of the first generation LMA, the LMA-ClassicTM, which has a maximum seal pressure of 20 cmH2O, but averages 16-18 cmH2O in actual practice.

In this study the investigators aim to test whether the air-QⓇ creates an airway seal pressure that is similar to the LMA-ProSealTM, whether the position of the air-QⓇ in relation to the vocal cords, as assessed by fiberoptic endoscopy, is similar to that of the LMA-ProSealTM and whether airway morbidity is similar between the air-QⓇ and the LMA-ProSealTM.


Condition Intervention Phase
Difficult Airway
Anesthesia; Functional
Device: Laryngeal Mask Airway (LMA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Air-Q Intubating Laryngeal Airway Versus the LMA-Proseal: A Prospective, Randomized Trial of Airway Seal Pressure

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Airway Seal Pressure [ Time Frame: Intraoperative (day 1) ] [ Designated as safety issue: Yes ]
    The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.


Secondary Outcome Measures:
  • Grossly Visible Blood or Bile on LMA [ Time Frame: Upon LMA removal ] [ Designated as safety issue: Yes ]
    At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.

  • Glottic View [ Time Frame: Intraoperative (day 1) ] [ Designated as safety issue: No ]
    Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.

  • Airway Pathology [ Time Frame: Postoperative (day 1) in recovery room ] [ Designated as safety issue: Yes ]
    In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.

  • Airway Pathology [ Time Frame: Postoperative Day Two ] [ Designated as safety issue: No ]
    The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.


Enrollment: 100
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Air-Q LMA
Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
Device: Laryngeal Mask Airway (LMA)
Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.
Other Names:
  • Air-QⓇ intubating laryngeal mask(Mercury Medical,Clearwater, Fl.)
  • LMA-Proseal TM(LMA North America,San Diego, Ca.)
Experimental: Proseal LMA
LMA-Proseal TM (LMA North America, San Diego, Ca.)
Device: Laryngeal Mask Airway (LMA)
Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.
Other Names:
  • Air-QⓇ intubating laryngeal mask(Mercury Medical,Clearwater, Fl.)
  • LMA-Proseal TM(LMA North America,San Diego, Ca.)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are 18 years or greater may be included if they presenting for any elective surgery or procedure to take place in any anesthetic location and require placement of a LMA for their surgery or procedure.

Exclusion Criteria:

  • non-English speaking
  • pregnant
  • are a minor
  • are a prisoner
  • have impaired decision-making capacity or any condition for which the primary anesthesia team deems intubation with a tracheal tube to be necessary
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01328405

Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kristopher M Schroeder, MD University of Wisconsin School of Medicine and Public Health Department of Anesthesiology
  More Information

Publications:
Responsible Party: Kristopher Schroeder, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01328405     History of Changes
Other Study ID Numbers: 2009-0012
Study First Received: March 29, 2011
Results First Received: July 2, 2012
Last Updated: July 2, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014