Intravascular Access in Suspected/Confirmed COVID-19 Patient

Not Applicable

Completed

• Conditions: Cardiopulmonary Arrest; Shock; Emergency Medicine
• Interventions: Device: NIO® (Intraosseous access); Device: Standard of Care (Intravenous access)

• Registration Number: NCT04366947
• Lead Sponsor: Lazarski University

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 available

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-29
• Primary Completion: 2020-09-20
• Study Completion: 2020-10-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Success rate of first intravascular access attempt	1 day	successful placement of intravascular device

Secondary Outcome Measures

Name	Time	Method
complication rates	1 day	complication rates
number of attempts to successful access	1 day	number of attempts to successful access
time to infusion	1 day	time to therapy including but not limited to time to fluids, antibiotics, and antiarrythmics
ROSC	1 day	the rate of survival to hospital admission
time to successful access	1 day	time to successful access

Trial Locations

Locations (1)

Lazarsku University; 🇵🇱 Warsaw, Masovian, Poland