STorz Against Glidescope Effectiveness

Study Overview
=================
Brief Summary
-----------------
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.

Official Title
-----------------
Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway

Conditions
-----------------
Difficult Airway

Intervention / Treatment
-----------------
* Device: C-MAC
* Device: Glidescope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult 18 years of age Mallampati classification scale score of 3 or 4 Neck circumference greater than 40cm for males, 38 cm for females mouth opening less than 3cm, but greater than 2cm Exclusion Criteria: children prisoners history of easy intubation (success on first attempt with direct laryngoscopy) known unstable cervical spine injury emergency surgery nasal intubation route planned awake technique

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-MAC<br>Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation | Device: C-MAC<br>* C-MAC arm<br>|
| Active Comparator: Glidescope<br>Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation | Device: Glidescope<br>* Glidescope arm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Success Rate | Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation Time | Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide | 1 week | 
| Graded Score of Laryngeal View Achieved | Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view. | 1 week | 
| Number of Particpants Requiring Adjuncts to Assist Intubation | The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team. | 1 week | 
| Number of Participants With Observed Complications | Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
difficult airway, video laryngoscopy