NCT00785252WithdrawnNot Applicable
Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 countryStarted: September 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Time taken to place the device
Study Overview
Brief Summary
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible
Exclusion Criteria
- •Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English
Arms & Interventions
1
Experimental
EZIO
Intervention: Powered Intraosseous device (EZIO) (Device)
2
Experimental
Central line
Intervention: standard central line (Device)
Outcomes
Primary Outcomes
Time taken to place the device
Time Frame: ED visit
Secondary Outcomes
- Incidence of complications(ED visit)
- Costs for each of the two methods(Ed visit)
Investigators
Study Sites (1)
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