Clinical Evaluation of the Storz CMAC Laryngoscope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00956592
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : March 9, 2011
Last Update Posted : April 5, 2018
Information provided by (Responsible Party):
Michael Aziz, Oregon Health and Science University

August 10, 2009
August 11, 2009
January 25, 2011
March 9, 2011
April 5, 2018
October 2009
December 2010   (Final data collection date for primary outcome measure)
Measure of Intubation Success [ Time Frame: During each intubation in a 14 month period ]
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
First attempt intubation success [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00956592 on Archive Site
  • Intubation Time [ Time Frame: During laryngoscopy procedure ]
    Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
  • Number of Participants Intubated With a Rescue Device [ Time Frame: 1 year ]
  • Number of Participants With Complications [ Time Frame: 1 year ]
  • Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. [ Time Frame: 1 year ]
    Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved
  • Number of Particpants Requiring Adjuncts to Assist Intubation [ Time Frame: 1 year ]
  • Intubation Time [ Time Frame: 1 year ]
  • Rescue Devices Used [ Time Frame: 1 year ]
  • Complications [ Time Frame: 1 year ]
  • Laryngeal View Achieved [ Time Frame: 1 year ]
  • Use of Adjuncts to Assist Intubation [ Time Frame: 1 year ]
Not Provided
Not Provided
Clinical Evaluation of the Storz CMAC Laryngoscope
A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.
Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Intubation
  • Airway Management
  • Device: CMAC video laryngoscope
    Intubation utilizing the assistance of video enhancement
    Other Names:
    • CMAC
    • Storz laryngoscope
  • Device: Macintosh laryngoscope
    Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
    Other Name: Mac blade
  • Active Comparator: CMAC Video laryngoscope
    Subjects will have their intubation attempted first with the CMAC video laryngoscope
    Intervention: Device: CMAC video laryngoscope
  • Active Comparator: Macintosh blade
    Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade
    Intervention: Device: Macintosh laryngoscope
Jungbauer A, Schumann M, Brunkhorst V, Börgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:

    • mallampati classification 3
    • mallampati classification 4
    • Reduced mouth opening (<3cm)
    • reduced cervical motion
    • history of previous difficult intubation or multiple laryngoscopy attempts

Exclusion Criteria:

  • Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)
  • Patients who have contraindications to the administration of neuromuscular blocking drugs
  • Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
  • Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Michael Aziz, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Michael Aziz, MD Oregon Health and Science University
Oregon Health and Science University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP