Text Size

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

August 10, 2009
February 14, 2011
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00956592 on ClinicalTrials.gov Archive Site
  • Intubation Time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
  • Rescue Devices Used [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Laryngeal View Achieved [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Use of Adjuncts to Assist Intubation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intubation time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Rescue devices used [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Laryngeal view achieved [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Use of adjuncts to assist intubation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. Epub 2009 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00956592
IRB00003272
No
Michael Aziz, Assistant Professor, Oregon Health & Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Michael Aziz, MD Oregon Health and Science University
Oregon Health and Science University
July 2010

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