Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation

Study Overview
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Brief Summary
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This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.

Official Title
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Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.

Conditions
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Intubation Intratracheal, Airway Management, Emergency Treatment

Intervention / Treatment
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* Device: Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary Exclusion Criteria: Age under 18 years Laryngoscopy according to the algorithm of airway management not being indicated

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-MAC System<br> | Device: Intubation<br>* Tracheal Intubation with the assigned video laryngoscope<br>|
| Active Comparator: AP Advance<br> | Device: Intubation<br>* Tracheal Intubation with the assigned video laryngoscope<br>|
| Active Comparator: King Vision<br> | Device: Intubation<br>* Tracheal Intubation with the assigned video laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success |  | Immediately after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation on first attempt |  | Immediately after intubation | 
| Intubation time |  | Immediately after intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Out-of-hospital, airway management, intubation, video laryngoscope