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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01328405
First received: March 29, 2011
Last updated: October 1, 2015
Last verified: July 2012
Results First Received: July 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Conditions: Difficult Airway
Anesthesia; Functional
Intervention: Device: Laryngeal Mask Airway (LMA)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Air-Q LMA Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
Proseal LMA LMA-Proseal TM (LMA North America, San Diego, Ca.)

Participant Flow:   Overall Study
    Air-Q LMA   Proseal LMA
STARTED   52   48 
COMPLETED   52   48 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Air-Q LMA Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
Proseal LMA LMA-Proseal TM (LMA North America, San Diego, Ca.)
Total Total of all reporting groups

Baseline Measures
   Air-Q LMA   Proseal LMA   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   48   100 
Age 
[Units: Participants]
     
<=18 years   0   1   1 
Between 18 and 65 years   51   45   96 
>=65 years   1   2   3 
Age 
[Units: Years]
Mean (Standard Deviation)
 39  (12)   39  (14)   39  (13) 
Gender 
[Units: Participants]
     
Female   24   23   47 
Male   28   25   53 
Region of Enrollment 
[Units: Participants]
     
United States   52   48   100 


  Outcome Measures
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1.  Primary:   Airway Seal Pressure   [ Time Frame: Intraoperative (day 1) ]

2.  Secondary:   Grossly Visible Blood or Bile on LMA   [ Time Frame: Upon LMA removal ]

3.  Secondary:   Glottic View   [ Time Frame: Intraoperative (day 1) ]

4.  Secondary:   Airway Pathology   [ Time Frame: Postoperative (day 1) in recovery room ]

5.  Secondary:   Airway Pathology   [ Time Frame: Postoperative Day Two ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kristopher Schroeder
Organization: University of Wisconsin School of Medicine and Public Health
phone: 608-263-8100
e-mail: kmschro1@wisc.edu


Publications:

Responsible Party: 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: October 1, 2015
Health Authority: United States: Institutional Review Board