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Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route

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ClinicalTrials.gov Identifier: NCT01531686
Recruitment Status : Terminated (Slow rate of enrollment)
First Posted : February 13, 2012
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation

Brief Summary:
Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.

Condition or disease Intervention/treatment
Intraosseous Vascular Access Patients Requiring CT Exam Procedure: Intraosseous delivery of CT contrast dye

Detailed Description:
intraosseous vascular access in the proximal humerus can be used to delivery contrast dye for CT examination.

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
Study Start Date : March 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Intervention Details:
  • Procedure: Intraosseous delivery of CT contrast dye
    Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.
    Other Name: EZ-IO


Primary Outcome Measures :
  1. Adequate CT image [ Time Frame: at time of CT examination average time is within 24 hours ]
    ability to effectively administer the contrast medium needed for the indicated CT examination.

  2. number of participants with adverse events within 24 hours of CT exam [ Time Frame: within 24 hours of CT exam ]
    incidence of complications assocated with the administration of contrast medium through the intraosseous route.

  3. number of participants with adverse events within 30 days of CT exam [ Time Frame: within 30 days of CT exam ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients that have received intraosseous vascular access as standard of care and require CT examination
Criteria

Inclusion Criteria:

  • Aged 18 years or older
  • Has received intraosseous vascular access at the proximal humerus insertion site via EZ-IO as standard of care
  • Requires CT examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
  • Cognitively and physically able to give written consent to participate in the study

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
  • Allergy to contrast media
  • Imprisoned
  • Pregnant
  • Requires English language translation other than Spanish
  • Has received IO access with an IO catheter other than the EZ-IO system

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 ClinicalTrials.gov identifier (NCT number): NCT01531686


Locations
United States, Arizona
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
United States, California
Olive View UCLA Medical Center
Sylmar, California, United States, 91342
United States, Florida
Shands Critical Care Center and Cancer Hospital
Gainesville, Florida, United States, 32608
United States, South Carolina
Grand Strand Regional Medical
Myrtle Beach, South Carolina, United States, 29572
Sponsors and Collaborators
Vidacare Corporation
Investigators
Study Director: Thomas Philbeck, PhD Sponsor Company- Vidacare Corporation

Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01531686     History of Changes
Other Study ID Numbers: 2011-02
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by Vidacare Corporation:
intraosseous vascular access
CT examination