Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy

Study Overview
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Brief Summary
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The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified

Detailed Description
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The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia. The investigators plan a cluster randomized multiple crossover design, where each cluster is crossed over to the other treatment in the next period. The operating suites will be divided into 2 separate clusters consisting of 11 operating suites each. Randomization will consist of randomizing cluster 1 to use either video laryngoscope or direct laryngoscope, and cluster 2 to the alternative device in one-week blocks.

Official Title
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Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial

Conditions
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Intubation, Laryngoscopy

Intervention / Treatment
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* Device: GlideScope videolaryngoscope (Verathon, Bothell, WA 98011)
* Device: Direct laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia. Exclusion Criteria: The attending anesthesiologist prefers a specific approach for a particular patient Awake fiberoptic intubation is clinically indicated Insertion of double-lumen tube.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster randomized multiple crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: videolaryngoscopy<br>Initial intubation performed using GlideScope videolaryngoscope. | Device: GlideScope videolaryngoscope (Verathon, Bothell, WA 98011)<br>* After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.<br>|
| Active Comparator: conventional direct laryngoscopy<br>Initial intubation performed using direct laryngoscopy. | Device: Direct laryngoscopy<br>* After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of intubation attempts with the initial laryngoscopy instrument. | Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated. | From the start time of intubation to time of the end of surgery up to 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation failure | Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts. | From the start time of intubation to time of the end of surgery up to 45 minutes | 
| Any dental or airway injury | Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team. Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team. | From the start time of intubation to time of the end of surgery up to 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway, Videolaryngoscope, Direct Laryngoscope