Observation of Intraosseous Vascular Access in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01235078
Recruitment Status : Completed
First Posted : November 5, 2010
Last Update Posted : July 2, 2012
Information provided by (Responsible Party):
Vidacare Corporation

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.

Condition or disease Intervention/treatment
Patients Requiring Urgent Vascular Access Device: EZ-IO

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study of Intraosseous Vascular Access Compared to Central Venous Catheters in the Emergency Department
Study Start Date : April 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Group/Cohort Intervention/treatment
Intraosseous vascular access
subjects with urgent vascular access needs in whom intraosseous vascular access has been attempted and/or established.
Device: EZ-IO
powered intraosseous vascular access system
Other Name: EZ-IO by Vidacare, Powered intraosseous vascular access

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01235078

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

Responsible Party: Vidacare Corporation Identifier: NCT01235078     History of Changes
Other Study ID Numbers: 2010-04
First Posted: November 5, 2010    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes