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
  Purpose

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 Intervention
Intubation
Airway Management
Device: CMAC video laryngoscope
Device: Macintosh laryngoscope

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
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

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 300
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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

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

ClinicalTrials.gov processed this record on September 15, 2014