Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

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 medical personnel should be equipped with full personal protective equipment (PPE) for AGP in contact with suspected/confirmed COVID-19 patient. Therefore, it is reasonable to search for the most effective methods of intravascular access in those conditions.

Official Title
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Intraosseous Versus Intravenous Access During COVID-19 Patients Performed by Paramedics Wearing Level C Personal Protective Equipment. A Multi-center Prospective Randomized Crossover Single-blinded Simulation Trial

Conditions
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Emergencies, Cardiac Arrest

Intervention / Treatment
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* Device: Intravenous access
* Device: Intraosseous access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paramedic consent voluntary participation in the study none experience in resuscitation 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: Standard of Care (Intravenous Cannula)<br>obtaining intravascular access using a ready standard intravenous cannula | Device: Intravenous access<br>* obtaining intravascular access using a standard intravenous cannula<br>* Other names: IV;|
| Experimental: IO access using NIO® set<br>receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®. | Device: Intraosseous access<br>* obtaining intravascular access using a ready intravenous NIO needle set<br>* Other names: IO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful rate of first intravascular access attempt | successful placement of intravascular device | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to successful access |  | 1 day | 
| number of attempts to successful access | number of attempts to successful access | 1 day | 
| time to infusion | time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics | 1 day | 
| complication rates | complication rates | 1 day | 
| 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 | 
| Preferred intravascular access method | participants were asked which method of intravascular access they would prefer in a real-life resuscitation. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravascular access, COVID-19, personal protective equipment, medical simulation