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Intravascular Access in Suspected/Confirmed COVID-19 Patient

Sponsor
Lazarski University (Other)
Overall Status
Completed
CT.gov ID
NCT04366947
Collaborator
Poznan University of Medical Sciences (Other), Medical University of Bialystok (Other), Wroclaw Medical University (Other)
60
Enrollment
1
Location
2
Arms
6.5
Actual Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NIO® (Intraosseous access)
  • Device: Standard of Care (Intravenous access)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting
Actual Study Start Date :
Apr 14, 2020
Actual Primary Completion Date :
Sep 20, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standard of Care (Intravenous Cannula)

obtaining intravascular access using a ready standard intravenous cannula

Device: Standard of Care (Intravenous access)
obtaining intravascular access using a standard intravenous cannula
Other Names:
  • IV

    		•
    Experimental: Experimental: IO access using NIO® set

    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)
    obtaining intravascular access using a ready intravenous NIO needle set
    Other Names:
  • IO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success rate of first intravascular access attempt [1 day]

      successful placement of intravascular device

    Secondary Outcome Measures

    1. time to successful access [1 day]

      time to successful access

    2. number of attempts to successful access [1 day]

      number of attempts to successful access

    3. time to infusion [1 day]

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

    4. complication rates [1 day]

      complication rates

    5. ROSC [1 day]

      the rate of survival to hospital admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lazarsku University Warsaw Masovian Poland 02-662

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Lukasz Szarpak, PhD, Lazarski University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lukasz Szarpak, Assoc Prof PhD, Lazarski University
    ClinicalTrials.gov Identifier:
    NCT04366947
    Other Study ID Numbers:
    • IO_PPE_1
    First Posted:
    Apr 29, 2020
    Last Update Posted:
    Dec 19, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lukasz Szarpak, Assoc Prof PhD, Lazarski University
    intravascular access
    intraosseous access
    personal protective equipment
    cardiopulmonary resuscitation
    shock
    Additional relevant MeSH terms:
    Heart Arrest
    Emergencies

    Study Results

    No Results Posted as of Dec 19, 2020