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Clinical Evaluation of the Storz CMAC Laryngoscope

This study has been completed.
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00956592
First received: August 10, 2009
Last updated: February 14, 2011
Last verified: July 2010
History of Changes
Results First Received: January 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Intubation
Airway Management
Interventions: Device: CMAC video laryngoscope
Device: Macintosh laryngoscope

  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
Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 exclusions were noted for failure to follow the randomization

Reporting Groups
  Description
CMAC Video Laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
Macintosh Blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion

Participant Flow:   Overall Study
    CMAC Video Laryngoscope     Macintosh Blade  
STARTED     150     150  
COMPLETED     149     147  
NOT COMPLETED     1     3  
Protocol Violation                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
CMAC Video Laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
Macintosh Blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Total Total of all reporting groups

Baseline Measures
    CMAC Video Laryngoscope     Macintosh Blade     Total  
Number of Participants  
[units: participants]
 		  150     150     300  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     122     114     236  
>=65 years     28     36     64  
Age  
[units: years]
Mean ± Standard Deviation 		  53.8  ± 14.2     55.4  ± 14.5     54.6  ± 14.5  
Gender  
[units: participants]
 		     
Female     76     65     141  
Male     74     85     159  
Region of Enrollment  
[units: participants]
 		     
United States     150     150     300  



  Outcome Measures

1.  Primary:   Measure of Intubation Success   [ Time Frame: During each intubation in a 14 month period ]
  Show Outcome Measure 1

2.  Secondary:   Intubation Time   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Rescue Devices Used   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Complications   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Laryngeal View Achieved   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Use of Adjuncts to Assist Intubation   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Michael Aziz
Organization: Oregon Health & Science University
phone: 503-494-5581
e-mail: azizm@ohsu.edu


Publications:


Responsible Party: Michael Aziz, Assistant Professor, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00956592     History of Changes
Other Study ID Numbers: IRB00003272
Study First Received: August 10, 2009
Results First Received: January 25, 2011
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board