Intravascular Access in Suspected/Confirmed COVID-19 Patient

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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Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting

Conditions
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Emergency Medicine, Cardiopulmonary Arrest, Shock

Intervention / Treatment
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* Device: NIO® (Intraosseous access)
* Device: Standard of Care (Intravenous access)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Out-of-hospital cardiac arrest (OHCA) Adult ≥ 18 years old Non-traumatic cause of cardiac arrest Exclusion Criteria: Existing do-not-attempt-resuscitation order OHCA patients with contraindications to IO access or IV access Patients with signs of obvious death, e.g. rigor mortis

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 |
| --- | --- |
| Experimental: Standard of Care (Intravenous Cannula)<br>obtaining intravascular access using a ready standard intravenous cannula | Device: Standard of Care (Intravenous access)<br>* obtaining intravascular access using a standard intravenous cannula<br>* Other names: IV;|
| Experimental: 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: NIO® (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 |
| --- | --- | --- |
| Success 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 | 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 | 
| ROSC | the rate of survival to hospital admission | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock