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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 3, 2010
Last Updated Date	June 28, 2012
Start Date ^ICMJE	April 2010
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 28, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01235078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 28, 2012)	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.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Observation of Intraosseous Vascular Access in the Emergency Department
Official Title ^ICMJE	An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	patients requiring urgent vascular access
Condition ^ICMJE	Patients Requiring Urgent Vascular Access
Intervention ^ICMJE	Device: EZ-IO powered intraosseous vascular access system Other Name: EZ-IO by Vidacare, Powered intraosseous vascular access
Study Group/Cohort (s)	Intraosseous vascular access subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established. Intervention: Device: EZ-IO
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	105
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01235078
Other Study ID Numbers ^ICMJE	2010-04
Has Data Monitoring Committee	No
Responsible Party	Vidacare Corporation
Study Sponsor ^ICMJE	Vidacare Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vidacare Corporation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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