Intubation During Spinal Immobilization

Study Overview
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Brief Summary
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The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.

Official Title
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C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: Standard endotracheal tube
* Device: C-MAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study limited experience (<5 intubations) with real-life intubation using direct laryngoscopy novice phhysicians Exclusion Criteria: not meet the above criteria practice with any videolaryngoscopy wrist or low back diseases pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scenario A<br>manikin with normal standard airway | Device: Standard endotracheal tube<br>* 1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube<br>Device: C-MAC<br>* C-MAC introduced with a h size 3 blade.<br>|
| Experimental: Scenario B<br>Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor. | Device: Standard endotracheal tube<br>* 1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube<br>Device: C-MAC<br>* C-MAC introduced with a h size 3 blade.<br>|
| Experimental: Scenario C<br>Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor | Device: Standard endotracheal tube<br>* 1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube<br>Device: C-MAC<br>* C-MAC introduced with a h size 3 blade.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for successful intubation |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of intubation attempt | success rate of first intubation attempt | 1 day | 
| Cormack&Lehane grade | glottic view during intubation rate using Cormack&Lehane grade | 1 day | 
| Dental Compression | the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009) | 1 day | 
| Ease of intubation | To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endotracheal intubation, trauma, paramedic