Clinical Evaluation of the Storz CMAC Laryngoscope

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intubation, Airway Management

Intervention / Treatment
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* Device: CMAC video laryngoscope
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CMAC Video laryngoscope<br>Subjects will have their intubation attempted first with the CMAC video laryngoscope | Device: CMAC video laryngoscope<br>* Intubation utilizing the assistance of video enhancement<br>* Other names: Storz laryngoscope;|
| Active Comparator: Macintosh blade<br>Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade | Device: Macintosh laryngoscope<br>* Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade<br>* Other names: Mac blade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Intubation Success | 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 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 |  | 1 year | 
| Number of Participants With Complications |  | 1 year | 
| Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. | 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 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video laryngoscopy, Intubation success, Difficult airway, CMAC laryngoscope