Intravascular Access in Suspected/Confirmed COVID-19 Patient

NCT04366947 | Completed

• 1 other identifier: IO_PPE_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergency Medicine; Cardiopulmonary Arrest; Shock

Keywords

intravascular access; intraosseous access; personal protective equipment; cardiopulmonary resuscitation; shock

Outcome Measures

Primary Outcomes (1)

• Success rate of first intravascular access attempt

  successful placement of intravascular device

  1 day

Secondary Outcomes (5)

• time to successful access

  1 day

• number of attempts to successful access

  1 day

• time to infusion

  1 day

• complication rates

  1 day

• ROSC

  1 day

Study Arms (2)

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

NIO® (Intraosseous access) DEVICE

obtaining intravascular access using a ready intravenous NIO needle set

Also known as: IO

Experimental: IO access using NIO® set

Standard of Care (Intravenous access) DEVICE

obtaining intravascular access using a standard intravenous cannula

Also known as: IV

Standard of Care (Intravenous Cannula)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out-of-hospital cardiac arrest (OHCA)
• Adult ≥ 18 years old
• Non-traumatic cause of cardiac arrest

You may not qualify if:

• 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

Sponsors & Collaborators

• Lazarski University: lead
• Poznan University of Medical Sciences: collaborator
• Medical University of Bialystok: collaborator
• Wroclaw Medical University: collaborator

Study Sites (1)

Lazarsku University

Warsaw, Masovian Voivodeship, 02-662, Poland

Location

MeSH Terms

Conditions

Heart Arrest; Shock

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lukasz Szarpak, PhD

  Lazarski University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof PhD

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 29, 2020
• Study Start: April 14, 2020
• Primary Completion: September 20, 2020
• Study Completion: October 30, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

PL (1)