Intravascular Access in Suspected/Confirmed COVID-19 Patient | NCT04366947

Studies
Intravascular Access in Suspected/Confirmed COVID-19 Patient

NCT04366947

Sponsor

Lazarski University

Status

Completed

Last Update Posted

Dec 19, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Emergency Medicine
Cardiopulmonary Arrest
Shock

Interventions

NIO® (Intraosseous access)
Standard of Care (Intravenous access)

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 14, 2020Actual

Primary Completion Date

Sep 20, 2020Actual

Completion Date

Oct 30, 2020Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lukasz Szarpak, Assoc Prof PhD, Lazarski UniversityPrincipal Investigator

Lead Sponsor

Lazarski UniversityOTHER

Collaborators

Name	Class
Poznan University of Medical Sciences	OTHER
Medical University of Bialystok	OTHER
Wroclaw Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care (Intravenous Cannula)	Experimental	obtaining intravascular access using a ready standard intravenous cannula	Device: Standard of Care (Intravenous access)
Experimental: IO access using NIO® set	Experimental	receive an IO line in the proximal tibia localization. IO lines are placed using an FDA-approved device called an NIO®.	Device: NIO® (Intraosseous access)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIO® (Intraosseous access)	Device	obtaining intravascular access using a ready intravenous NIO needle set	Experimental: IO access using NIO® set

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate of first intravascular access attempt	successful placement of intravascular device	1 day

Secondary Outcomes

Measure	Description	Time Frame
time to successful access	time to successful access	1 day
number of attempts to successful access	number of attempts to successful access

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lukasz Szarpak, PhD	Lazarski University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lazarsku University		Warsaw	Masovian Voivodeship	02-662	Poland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

the investigators will decide after study finishing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D012769	Shock

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided