Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

NCT ID: NCT04366297

Last Updated: 2020-04-28

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-12

Study Completion Date

2020-02-25

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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Cardiac Arrest Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Intravenous access

Intervention Type DEVICE

obtaining intravascular access using a standard intravenous cannula

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

Intraosseous access

Intervention Type DEVICE

obtaining intravascular access using a ready intravenous NIO needle set

Interventions

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Intravenous access

obtaining intravascular access using a standard intravenous cannula

Intervention Type DEVICE

Intraosseous access

obtaining intravascular access using a ready intravenous NIO needle set

Intervention Type DEVICE

Other Intervention Names

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IV IO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Łukasz Szarpak

Assoc Prof PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacek Smereka, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Locations

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Lazarski Univeristy

Warsaw, , Poland

Site Status

Countries

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Poland

References

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Smereka J, Szarpak L, Filipiak KJ, Jaguszewski M, Ladny JR. Which intravascular access should we use in patients with suspected/confirmed COVID-19? Resuscitation. 2020 Jun;151:8-9. doi: 10.1016/j.resuscitation.2020.04.014. Epub 2020 Apr 15. No abstract available.

Reference Type BACKGROUND
PMID: 32304800 (View on PubMed)

Other Identifiers

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IO_PPE_MS_1

Identifier Type: -

Identifier Source: org_study_id

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