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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02305511
Other study ID # IO/2014/01
Secondary ID
Status Recruiting
Phase N/A
First received November 27, 2014
Last updated December 1, 2014
Start date November 2014
Est. completion date December 2014

Study information

Verified date November 2014
Source International Institute of Rescue Research and Education
Contact Andrzej Kurowski
Phone +48500186225
Email andrzejkurowski987@gmail.com
Is FDA regulated No
Health authority Poland: Ministry of Science and Higher Education
Study type Interventional

Clinical Trial Summary

The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- give voluntary consent to participate in the study

- minimum 1 year of work experience in emergency medicine

- experienced emergency medical personnel - EMS-paramedics

Exclusion Criteria:

- not meet the above criteria

- wrist or low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Peripheral venous catheterization
Cannulation using standard method
Jamshidi
intraosseous access using the Jamshidi device
BIG
intraosseous access using the BIG device
Cook
intraosseous access using the Cook device
EZIO
intraosseous access using the EZIO device

Locations

Country Name City State
Poland International Institute of Rescue Research and Education Warsaw Masovia

Sponsors (1)

Lead Sponsor Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate on first attempt 1 day No
Secondary Ease of use Ease of use as reported by participants 1 day No
Secondary Time to successfully perform Time to successfully perform the intraosseous access 1 day No
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