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Intravascular Access in Suspected/Confirmed COVID-19 Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366947
Recruitment Status : Active, not recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Poznan University of Medical Sciences
Medical University of Bialystok
Wroclaw Medical University
Information provided by (Responsible Party):
Lukasz Szarpak, Lazarski University

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
Emergency Medicine Cardiopulmonary Arrest Shock Device: NIO® (Intraosseous access) Device: Standard of Care (Intravenous access) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 14, 2020
Estimated Primary Completion Date : May 20, 2020
Estimated Study Completion Date : May 20, 2020

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 Name: 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 Name: IO




Primary Outcome Measures :
  1. Success rate of first intravascular access attempt [ Time Frame: 1 day ]
    successful placement of intravascular device


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366947


Locations
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Poland
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
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Study Chair: Lukasz Szarpak, PhD Lazarski University
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Responsible Party: Lukasz Szarpak, Assoc Prof PhD, Lazarski University
ClinicalTrials.gov Identifier: NCT04366947    
Other Study ID Numbers: IO_PPE_1
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: the investigators will decide after study finishing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lukasz Szarpak, Lazarski University:
intravascular access
intraosseous access
personal protective equipment
cardiopulmonary resuscitation
shock
Additional relevant MeSH terms:
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Heart Arrest
Emergencies
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases