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Intravascular Access in Suspected/Confirmed COVID-19 Patient

NCT ID: NCT04366947

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Emergency Medicine Cardiopulmonary Arrest Shock

Keywords

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intravascular access intraosseous access personal protective equipment cardiopulmonary resuscitation shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of Care (Intravenous Cannula)

obtaining intravascular access using a ready standard intravenous cannula

Group Type EXPERIMENTAL

Standard of Care (Intravenous access)

Intervention Type DEVICE

obtaining intravascular access using a standard intravenous cannula

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®.

Group Type EXPERIMENTAL

NIO® (Intraosseous access)

Intervention Type DEVICE

obtaining intravascular access using a ready intravenous NIO needle set

Interventions

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NIO® (Intraosseous access)

obtaining intravascular access using a ready intravenous NIO needle set

Intervention Type DEVICE

Standard of Care (Intravenous access)

obtaining intravascular access using a standard intravenous cannula

Intervention Type DEVICE

Other Intervention Names

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IO IV

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role collaborator

Medical University of Bialystok

OTHER

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role collaborator

Lazarski University

OTHER

Sponsor Role lead

Responsible Party

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Lukasz Szarpak

Assoc Prof PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukasz Szarpak, PhD

Role: STUDY_CHAIR

Lazarski University

Locations

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Lazarsku University

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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IO_PPE_1

Identifier Type: -

Identifier Source: org_study_id