Clinical Evaluation of the Storz CMAC Laryngoscope

April 3, 2018 updated by: Michael Aziz, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Mac blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During each intubation in a 14 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time
Time Frame: During laryngoscopy procedure
Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
During laryngoscopy procedure
Number of Participants Intubated With a Rescue Device
Time Frame: 1 year
1 year
Number of Participants With Complications
Time Frame: 1 year
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
1 year
Number of Particpants Requiring Adjuncts to Assist Intubation
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (ESTIMATE)

August 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00003272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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