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OpenTrials
Completed

NCT Number: NCT04366297

Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intravenous access

Device

obtaining intravascular access using a standard intravenous cannula

Other names: IV

Intraosseous access

Device

obtaining intravascular access using a ready intravenous NIO needle set

Other names: IO

Primary outcomes

  1. successful 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

  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. ease of use

    Time frame: 1 day

    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

  6. Preferred intravascular access method

    Time frame: 1 day

    participants were asked which method of intravascular access they would prefer in a real-life resuscitation.

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

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Apr 28, 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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