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OpenTrials
Completed

NCT Number: NCT04366947

Intravascular Access in Suspected/Confirmed COVID-19 Patient

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.

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Key information

Conditions

Emergency Medicine Cardiopulmonary Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lazarsku University

Warsaw, Masovian Voivodeship, 02-662, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIO® (Intraosseous access)

Device

obtaining intravascular access using a ready intravenous NIO needle set

Other names: IO

Standard of Care (Intravenous access)

Device

obtaining intravascular access using a standard intravenous cannula

Other names: IV

Primary outcomes

  1. Success rate of first intravascular access attempt

    Time frame: 1 day

    successful placement of intravascular device

Secondary outcomes

  1. time to successful access

    Time frame: 1 day

    time to successful access

  2. number of attempts to successful access

    Time frame: 1 day

    number of attempts to successful access

  3. time to infusion

    Time frame: 1 day

    time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics

  4. complication rates

    Time frame: 1 day

    complication rates

  5. ROSC

    Time frame: 1 day

    the rate of survival to hospital admission

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Collaborators

  • Medical University of Bialystok
  • Poznan University of Medical Sciences
  • Wroclaw Medical University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2020
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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