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Observation of Intraosseous Vascular Access in the Emergency Department

An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01235078
Enrollment
105
Registered
2010-11-05
Start date
2010-04-30
Completion date
2011-07-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Requiring Urgent Vascular Access

Brief summary

The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.

Interventions

DEVICEEZ-IO

powered intraosseous vascular access system

Sponsors

Vidacare Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.

Exclusion criteria

* Fracture in target bone, or significant trauma to the site * Excessive tissue and/or absence of adequate anatomical landmarks in target bone * Infection in target area * IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone

Design outcomes

Primary

MeasureTime frameDescription
Time to vascular accessat time of patient's arrival to emergency department, average within 10 minutesTime from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.

Secondary

MeasureTime frameDescription
Incidence of complications with intraosseous devicetime subject has intraosseous vascular access, an average of 24 hoursReported complications by intraosseous device operators.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026