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Observation of Intraosseous Vascular Access in the Emergency Department

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ClinicalTrials.gov Identifier: NCT01235078
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):

November 3, 2010
November 5, 2010
July 2, 2012
April 2010
July 2011   (Final data collection date for primary outcome measure)
Time to vascular access [ Time Frame: at time of patient's arrival to emergency department, average within 10 minutes ]
Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.
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Complete list of historical versions of study NCT01235078 on ClinicalTrials.gov Archive Site
Incidence of complications with intraosseous device [ Time Frame: time subject has intraosseous vascular access, an average of 24 hours ]
Reported complications by intraosseous device operators.
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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
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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Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
patients requiring urgent vascular access
Patients Requiring Urgent Vascular Access
Device: EZ-IO
powered intraosseous vascular access system
Other Name: EZ-IO by Vidacare, Powered intraosseous vascular access
Intraosseous vascular access
subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.
Intervention: Device: EZ-IO
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
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Vidacare Corporation
Vidacare Corporation
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Vidacare Corporation
June 2012