Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

April 27, 2020 updated by: Łukasz Szarpak, Lazarski University

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

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)

41

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
      • Warsaw, Poland, 02-662
        • Lazarski Univeristy

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Crossover 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful 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
time to successful access
Time Frame: 1 day
1 day
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
ease of use
Time Frame: 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
1 day
Preferred intravascular access method
Time Frame: 1 day
participants were asked which method of intravascular access they would prefer in a real-life resuscitation.
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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 12, 2020

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

February 25, 2020

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IO_PPE_MS_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

the investigators will add data into manuscript

Drug and device information, study documents

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

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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