Intravascular Access in Suspected/Confirmed COVID-19 Patient

Shock Clinical Trial

Official title:

Comparison of Intraosseous Versus Intravenous Access in Suspected/Confirmed COVID-19 Patient in Prehospital Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366947
• Other study ID #: IO_PPE_1
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: December 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: 60
• Est. completion date: October 30, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Emergencies
• Emergency Medicine
• Heart Arrest
• Shock

Intervention

Device:
• NIO® (Intraosseous access)
obtaining intravascular access using a ready intravenous NIO needle set
• Standard of Care (Intravenous access)
obtaining intravascular access using a standard intravenous cannula

Locations

Country	Name	City	State
Poland	Lazarsku University	Warsaw	Masovian

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of first intravascular access attempt	successful placement of intravascular device	1 day
Secondary	time to successful access	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	ROSC	the rate of survival to hospital admission	1 day