Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Study Overview
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Brief Summary
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The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Detailed Description
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Intubation will be carried out in full personal protective equipment conditions of the operator

Official Title
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Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope

Conditions
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Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest, Influenza, Safety Issues

Intervention / Treatment
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* Procedure: Direct laryngoscopy
* Procedure: Vie Scope laryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients requiring out-of-hospital intubation Exclusion Criteria: Patient under 18 years old Patients with criteria predictive of impossible intubation under direct laryngoscopy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct laryngoscopy<br>Intubation will be done using direct laryngoscopy. The standard intubation procedure is to use a styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the guidelines on difficult airway management. | Procedure: Direct laryngoscopy<br>* standard laryngoscope with Macintosh blade<br>* Other names: MAC;|
| Active Comparator: Vie Scope laryngoscopy<br>Intubation will be done using Vie Scope laryngoscopy | Procedure: Vie Scope laryngoscopy<br>* Vie Scope with dedicated bougie stylet<br>* Other names: VCE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation success rate during at the first laryngoscopy | Definition of failed intubation: Time to intubation is longer than 120 seconds or wrong placement of endotracheal tube (For example : Esophageal intubation etc.) | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation difficulty Scale score | Intubation difficulty assessed by Intubation difficulty Scale score | 10 min | 
| Complications related to tracheal intubation | Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation | 10 min | 
| Time to completion of tracheal intubation (TI) procedure | Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated | 10 min | 
| Duration of the interruption of chest compression during ETI procedure | Duration of the interruption of chest compression during ETI procedure | 10 min | 
| Laryngeal View during intubation | We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system. | 10 min | 
| POGO score | self-reported percentage of glottis opening (POGO) score | 10 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, endotracheal intubation, personal protective equipment, laryngoscope, Vie Scope, COVID-19, SARS-CoV-2, emergency medicine