Intravascular Access of COVID-19 Patient Under Personal Protective Equipment

Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366297
• Other study ID #: IO_PPE_MS_1
• Status: Completed
• Phase: N/A
• Start date: January 12, 2020
• Est. completion date: February 25, 2020

Study information

• Verified date: April 2020
• Source: Lazarski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Emergencies

Intervention

Device:
• Intravenous access
obtaining intravascular access using a standard intravenous cannula
• Intraosseous access
obtaining intravascular access using a ready intravenous NIO needle set

Locations

Country	Name	City	State
Poland	Lazarski Univeristy	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Lazarski University	Medical University of Bialystok, Poznan University of Medical Sciences, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

References & 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 Apr 15;151:8-9. doi: 10.1016/j.resuscitation.2020.04.014. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful rate of first intravascular access attempt	successful placement of intravascular device	1 day
Secondary	time to successful access		1 day
Secondary	number of attempts to successful access	number of attempts to successful access	1 day
Secondary	time to infusion	time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics	1 day
Secondary	complication rates	complication rates	1 day
Secondary	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	1 day
Secondary	Preferred intravascular access method	participants were asked which method of intravascular access they would prefer in a real-life resuscitation.	1 day