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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04366297
Other study ID # IO_PPE_MS_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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