Comparison of VieScope vs. Macintosh Laryngoscope for Intubation in Level Cpersonal Protective Equipment Conditions

Study Overview
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Brief Summary
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The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.

Official Title
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Comparison of VieScope Versus Macintosh Laryngoscope for Emergency Intubation Under Level C Personal Protective Equipment Conditions

Conditions
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Tracheal Intubation, Infection, Projection

Intervention / Treatment
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* Device: The standard Macintosh laryngoscope
* Device: The Vie Scope laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paramedic consent voluntary participation in the study none experience in Vie Scope none experience in intubation with personal protective equipment Exclusion Criteria: refusal to participate in the study

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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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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regurgitation<br>intubation in regurgitation condition | Device: The standard Macintosh laryngoscope<br>* intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet<br>* Other names: MAC;Device: The Vie Scope laryngoscope<br>* intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter<br>* Other names: VSCOPE;|
| Experimental: Tongue edema<br>intubation in Tongue edema condition | Device: The standard Macintosh laryngoscope<br>* intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet<br>* Other names: MAC;Device: The Vie Scope laryngoscope<br>* intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter<br>* Other names: VSCOPE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to intubation | time from pick up device to the final placement tube in trachea | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of intubation | A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform | 1 day | 
| Number of optimalization maneuvers | the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation | 1 day | 
| Procedure Ease of use | self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy | 1 day | 
| the degree of visibility of the glottis | The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures. | 1 day | 
| Cormack - Lehane grade | self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, tracheal intubation, laryngoscope, personal protective equipment