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Completed

NCT Number: NCT00956592

Clinical Evaluation of the Storz CMAC Laryngoscope

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.

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Key information

Conditions

Intubation Airway Management

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CMAC video laryngoscope

Device

Intubation utilizing the assistance of video enhancement

Other names: CMAC, Storz laryngoscope

Macintosh laryngoscope

Device

Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Other names: Mac blade

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2009
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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