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CompletedNCT01235078Updated Dec 15, 2025

Observation of Intraosseous Vascular Access in the Emergency Department

An observational study in Patients Requiring Urgent Vascular Access, sponsored by Vidacare Corporation. Completed at 6 sites in United States. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Vidacare Corporation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
105
Sex
All
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Study 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.

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Conditions studied

  • Patients Requiring Urgent Vascular Access
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In context

Lead sponsor

Vidacare Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients requiring urgent vascular access

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
105 participants (actual)

Groups and cohorts

  • Intraosseous vascular access

    subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.

    Device: EZ-IO

Interventions

  • DeviceEZ-IO

    powered intraosseous vascular access system

    Also known as: EZ-IO by Vidacare, Powered intraosseous vascular access

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What researchers measure

Primary outcomes

  1. Time to vascular access

    Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.

    Time frame: at time of patient's arrival to emergency department, average within 10 minutes

Secondary outcomes

  1. Incidence of complications with intraosseous device

    Reported complications by intraosseous device operators.

    Time frame: time subject has intraosseous vascular access, an average of 24 hours

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Study locations

6 sites
  • Gulf Breeze Hospital
    Gulf Breeze, Florida 32561, United States
  • Baptist Hospital Pensacola
    Pensacola, Florida 32522, United States
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
  • Omaha Children's Hospital and Medical Center
    Omaha, Nebraska 68198, United States
  • Methodist Healthcare, University Hospital
    Memphis, Tennessee 38104, United States
  • Texas Tech University Medical Center
    El Paso, Texas 79905, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01235078
Lead sponsor
Vidacare Corporation
Responsible party
Sponsor
First posted
Nov 5, 2010
Start date
Apr 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Dec 15, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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