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Clinical Evaluation of the Storz CMAC Laryngoscope

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ClinicalTrials.gov Identifier: NCT00956592
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : March 9, 2011
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Aziz, Oregon Health and Science University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Intubation
Airway Management
Interventions: Device: CMAC video laryngoscope
Device: Macintosh laryngoscope

  Participant Flow

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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      122  81.3%      114  76.0%      236  78.7% 
>=65 years      28  18.7%      36  24.0%      64  21.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (14.2)   55.4  (14.5)   54.6  (14.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      76  50.7%      65  43.3%      141  47.0% 
Male      74  49.3%      85  56.7%      159  53.0% 
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 ]

2.  Secondary:   Intubation Time   [ Time Frame: During laryngoscopy procedure ]

3.  Secondary:   Number of Participants Intubated With a Rescue Device   [ Time Frame: 1 year ]

4.  Secondary:   Number of Participants With Complications   [ Time Frame: 1 year ]

5.  Secondary:   Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.   [ Time Frame: 1 year ]

6.  Secondary:   Number of Particpants Requiring Adjuncts to Assist Intubation   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00956592     History of Changes
Other Study ID Numbers: IRB00003272
First Submitted: August 10, 2009
First Posted: August 11, 2009
Results First Submitted: January 25, 2011
Results First Posted: March 9, 2011
Last Update Posted: April 5, 2018