Intravascular Access in Suspected/Confirmed COVID-19 Patient

Lazarski University

Status: Completed

Conditions: Emergency Medicine; Shock; Cardiopulmonary Arrest

Treatments: Device: NIO® (Intraosseous access); Device: Standard of Care (Intravenous access)

Study type: Interventional

Funder types: Other

Identifiers

NCT04366947

IO_PPE_1

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard of Care (Intravenous Cannula)

Experimental group

Description:

obtaining intravascular access using a ready standard intravenous cannula

Treatment:

Device: Standard of Care (Intravenous access)

Experimental: IO access using NIO® set

Experimental group

Description:

receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®.

Treatment:

Device: NIO® (Intraosseous access)