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Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

Sponsor
Lazarski University (Other)
Overall Status
Completed
CT.gov ID
NCT04366297
Collaborator
Poznan University of Medical Sciences (Other), Medical University of Bialystok (Other), Wroclaw Medical University (Other)
41
Enrollment
1
Location
2
Arms
1.4
Actual Duration (Months)
28.4
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: Intravenous access
  • Device: Intraosseous access
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 12, 2020
Actual Primary Completion Date :
Feb 25, 2020
Actual Study Completion Date :
Feb 25, 2020

Arms and Interventions

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

obtaining intravascular access using a ready standard intravenous cannula

Device: Intravenous access
obtaining intravascular access using a standard intravenous cannula
Other Names:
  • IV

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      successful placement of intravascular device

    Secondary Outcome Measures

    1. time to successful access [1 day]

    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. ease of use [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 [1 day]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lazarski Univeristy Warsaw Poland 02-662

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jacek Smereka, PhD, Wroclaw Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Łukasz Szarpak, Assoc Prof PhD, Lazarski University
    ClinicalTrials.gov Identifier:
    NCT04366297
    Other Study ID Numbers:
    • IO_PPE_MS_1
    First Posted:
    Apr 28, 2020
    Last Update Posted:
    Apr 28, 2020
    Last Verified:
    Apr 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
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Łukasz Szarpak, Assoc Prof PhD, Lazarski University
    intravascular access
    COVID-19
    personal protective equipment
    medical simulation
    Additional relevant MeSH terms:
    COVID-19
    Emergencies

    Study Results

    No Results Posted as of Apr 28, 2020