search
Back to results

Intravascular Access in Suspected/Confirmed COVID-19 Patient

Primary Purpose

Emergency Medicine, Cardiopulmonary Arrest, Shock

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
NIO® (Intraosseous access)
Standard of Care (Intravenous access)
Sponsored by
Lazarski University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergency Medicine focused on measuring intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lazarsku University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard of Care (Intravenous Cannula)

Experimental: 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

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

Secondary Outcome Measures

time to successful access
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
ROSC
the rate of survival to hospital admission

Full Information

First Posted
April 23, 2020
Last Updated
December 17, 2020
Sponsor
Lazarski University
Collaborators
Poznan University of Medical Sciences, Medical University of Bialystok, Wroclaw Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04366947
Brief Title
Intravascular Access in Suspected/Confirmed COVID-19 Patient
Official Title
Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
October 30, 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
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
Emergency Medicine, Cardiopulmonary Arrest, Shock
Keywords
intravascular access, intraosseous access, personal protective equipment, cardiopulmonary resuscitation, shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (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
Experimental: 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)
NIO® (Intraosseous access)
Other Intervention Name(s)
IO
Intervention Description
obtaining intravascular access using a ready intravenous NIO needle set
Intervention Type
Device
Intervention Name(s)
Standard of Care (Intravenous access)
Other Intervention Name(s)
IV
Intervention Description
obtaining intravascular access using a standard intravenous cannula
Primary Outcome Measure Information:
Title
Success 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
Description
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
ROSC
Description
the rate of survival to hospital admission
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak, PhD
Organizational Affiliation
Lazarski University
Official's Role
Study Chair
Facility Information:
Facility Name
Lazarsku University
City
Warsaw
State/Province
Masovian
ZIP/Postal Code
02-662
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
the investigators will decide after study finishing

Learn more about this trial

Intravascular Access in Suspected/Confirmed COVID-19 Patient

We'll reach out to this number within 24 hrs