Endotracheal Intubation in Prehospital Scenario

Study Overview
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Brief Summary
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We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.

Official Title
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Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial

Conditions
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Endotracheal Intubation

Intervention / Treatment
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* Device: C-MAC laryngoscope
* Device: Macintosh laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: give voluntary consent to participate in the study maximum 1 year of work experience in medicine minimum 50 clinical intubations paramedics Exclusion Criteria: not meet the above criteria wrist or low back diseases

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: Position 1<br>Standard position during intubation. Intubator is behind head of the victim, propped up on both elbows | Device: C-MAC laryngoscope<br>* Intubation performed using C-MAC laryngoscope<br>* Other names: C-MAC;Device: Macintosh laryngoscope<br>* Intubation performed using laryngoscope with Macintosh blade<br>* Other names: C-MAC;|
| Experimental: Position 2<br>Intubator is behind head of the victim, lies on the left side | Device: C-MAC laryngoscope<br>* Intubation performed using C-MAC laryngoscope<br>* Other names: C-MAC;Device: Macintosh laryngoscope<br>* Intubation performed using laryngoscope with Macintosh blade<br>* Other names: C-MAC;|
| Experimental: Position 3<br>Intubator stands astride the victims, intubated using the face-to-face | Device: C-MAC laryngoscope<br>* Intubation performed using C-MAC laryngoscope<br>* Other names: C-MAC;Device: Macintosh laryngoscope<br>* Intubation performed using laryngoscope with Macintosh blade<br>* Other names: C-MAC;|

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, second and third intubation attempt | 1 day | 
| cumulative success ratios related to time | cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios | 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 | 
| 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 |