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
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
None


  More Information
  Hide More Information

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: Kristopher Schroeder, 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