Intravascular Access in Suspected/Confirmed COVID-19 Patient

December 17, 2020 updated by: Lukasz Szarpak, Lazarski University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian
      • Warsaw, Masovian, Poland, 02-662
        • Lazarsku University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of first intravascular access attempt
Time Frame: 1 day
successful placement of intravascular device
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lazarski University

Collaborators

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

Investigators

  • Study Chair: Lukasz Szarpak, PhD, Lazarski University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

September 20, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 28, 2020

First Posted (Actual)

April 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IO_PPE_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the investigators will decide after study finishing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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