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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intubation Airway Management Device: CMAC video laryngoscope Device: Macintosh laryngoscope Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: CMAC Video laryngoscope
Subjects will have their intubation attempted first with the CMAC video laryngoscope
Device: CMAC video laryngoscope
Intubation utilizing the assistance of video enhancement
Other Names:
  • CMAC
  • Storz laryngoscope
Active Comparator: Macintosh blade
Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade
Device: Macintosh laryngoscope
Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Other Name: Mac blade



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Intubation Time [ Time Frame: During laryngoscopy procedure ]
    Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation

  2. Number of Participants Intubated With a Rescue Device [ Time Frame: 1 year ]
  3. Number of Participants With Complications [ Time Frame: 1 year ]
  4. 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

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


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956592


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Michael Aziz, MD Oregon Health and Science University

Publications:
Responsible Party: Michael Aziz, Associate Professor Department of Anesthesiology & Perioperative Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00956592     History of Changes
Other Study ID Numbers: IRB00003272
First Posted: August 11, 2009    Key Record Dates
Results First Posted: March 9, 2011
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Michael Aziz, Oregon Health and Science University:
Video laryngoscopy
Intubation success
Difficult airway
CMAC laryngoscope