Intravascular Access in Suspected/Confirmed COVID-19 Patient

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04366947

Enrollment

Registered

2020-04-29

Start date

2020-04-14

Completion date

2020-10-30

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Arrest, Emergency Medicine, Shock

Keywords

intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock

Brief summary

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.

Interventions

DEVICENIO® (Intraosseous access)

obtaining intravascular access using a ready intravenous NIO needle set

DEVICEStandard of Care (Intravenous access)

obtaining intravascular access using a standard intravenous cannula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Success rate of first intravascular access attempt	1 day	successful placement of intravascular device

Secondary

Measure	Time frame	Description
time to successful access	1 day	time to successful access
number of attempts to successful access	1 day	number of attempts to successful access
time to infusion	1 day	time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
complication rates	1 day	complication rates
ROSC	1 day	the rate of survival to hospital admission

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026