Observation of Intraosseous Vascular Access in the Emergency Department

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01235078
First received: November 3, 2010
Last updated: June 28, 2012
Last verified: June 2012

November 3, 2010
June 28, 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 ] [ Designated as safety issue: No ]
Time from opening intraosseous device packaging to initial infusion of drugs or fluids via the intraosseous route.
Not Provided
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 ] [ Designated as safety issue: No ]
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01235078
2010-04
No
Vidacare Corporation
Vidacare Corporation
Not Provided
Not Provided
Vidacare Corporation
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP