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Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

Primary Purpose

Cardiac Arrest, Emergencies

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Intravenous access
Intraosseous access
Sponsored by
Lazarski University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring intravascular access, COVID-19, personal protective equipment, medical simulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lazarski Univeristy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of Care (Intravenous Cannula)

IO access using NIO® set

Arm Description

obtaining intravascular access using a ready standard intravenous cannula

receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®.

Outcomes

Primary Outcome Measures

successful rate of first intravascular access attempt
successful placement of intravascular device

Secondary Outcome Measures

time to successful access
number of attempts to successful access
number of attempts to successful access
time to infusion
time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
complication rates
complication rates
ease of use
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
Preferred intravascular access method
participants were asked which method of intravascular access they would prefer in a real-life resuscitation.

Full Information

First Posted
April 23, 2020
Last Updated
April 27, 2020
Sponsor
Lazarski University
Collaborators
Poznan University of Medical Sciences, Medical University of Bialystok, Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04366297
Brief Title
Intravascular Access of COVID-19 Patient Under Personal Protective Equipment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2020 (Actual)
Primary Completion Date
February 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lazarski University
Collaborators
Poznan University of Medical Sciences, Medical University of Bialystok, Wroclaw Medical University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Emergencies
Keywords
intravascular access, COVID-19, personal protective equipment, medical simulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (Intravenous Cannula)
Arm Type
Experimental
Arm Description
obtaining intravascular access using a ready standard intravenous cannula
Arm Title
IO access using NIO® set
Arm Type
Experimental
Arm Description
receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®.
Intervention Type
Device
Intervention Name(s)
Intravenous access
Other Intervention Name(s)
IV
Intervention Description
obtaining intravascular access using a standard intravenous cannula
Intervention Type
Device
Intervention Name(s)
Intraosseous access
Other Intervention Name(s)
IO
Intervention Description
obtaining intravascular access using a ready intravenous NIO needle set
Primary Outcome Measure Information:
Title
successful rate of first intravascular access attempt
Description
successful placement of intravascular device
Time Frame
1 day
Secondary Outcome Measure Information:
Title
time to successful access
Time Frame
1 day
Title
number of attempts to successful access
Description
number of attempts to successful access
Time Frame
1 day
Title
time to infusion
Description
time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
Time Frame
1 day
Title
complication rates
Description
complication rates
Time Frame
1 day
Title
ease of use
Description
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
Time Frame
1 day
Title
Preferred intravascular access method
Description
participants were asked which method of intravascular access they would prefer in a real-life resuscitation.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Smereka, PhD
Organizational Affiliation
Wroclaw Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lazarski Univeristy
City
Warsaw
ZIP/Postal Code
02-662
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the investigators will add data into manuscript
Citations:
PubMed Identifier
32304800
Citation
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.
Results Reference
background

Learn more about this trial

Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

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