Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

NCT04366297 | Completed

• 1 other identifier: IO_PPE_MS_1
• Study Type: interventional
• Target: 41
• 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

Cardiac Arrest; Emergencies

Keywords

intravascular access; COVID-19; personal protective equipment; medical simulation

Outcome Measures

Primary Outcomes (1)

• successful rate of first intravascular access attempt

  successful placement of intravascular device

  1 day

Secondary Outcomes (6)

• time to successful access

  1 day

• number of attempts to successful access

  1 day

• time to infusion

  1 day

• complication rates

  1 day

• ease of use

  1 day

Study Arms (2)

Standard of Care (Intravenous Cannula)

EXPERIMENTAL

obtaining intravascular access using a ready standard intravenous cannula

Device: Intravenous access

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: Intraosseous access

Interventions

Intravenous access DEVICE

obtaining intravascular access using a standard intravenous cannula

Also known as: IV

Standard of Care (Intravenous Cannula)

Intraosseous access DEVICE

obtaining intravascular access using a ready intravenous NIO needle set

Also known as: IO

IO access using NIO® set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paramedic
• consent voluntary participation in the study
• none experience in resuscitation with personal protective equipment

You may not qualify if:

• refusal to participate in the study

Sponsors & Collaborators

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

Study Sites (1)

Lazarski Univeristy

Warsaw, 02-662, Poland

Location

Related Publications (1)

• 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.

  PMID: 32304800 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Emergencies; COVID-19

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jacek Smereka, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: January 12, 2020
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

PL (1)