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
1 other identifier
observational
105
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 3, 2010
CompletedFirst Posted
Study publicly available on registry
November 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 15, 2025
June 1, 2012
1.2 years
November 3, 2010
December 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to vascular access
Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.
at time of patient's arrival to emergency department, average within 10 minutes
Secondary Outcomes (1)
Incidence of complications with intraosseous device
time subject has intraosseous vascular access, an average of 24 hours
Study Arms (1)
Intraosseous vascular access
subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.
Interventions
powered intraosseous vascular access system
Eligibility Criteria
patients requiring urgent vascular access
You may qualify if:
- Patients requiring vascular access who would otherwise receive a central venous catheter due to lack of other options.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2010
First Posted
November 5, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 15, 2025
Record last verified: 2012-06