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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01531686
First received: February 3, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Intraosseous Vascular Access Patients Requiring CT Exam
Procedure: Intraosseous delivery of CT contrast dye

Study Type: Observational
Study Design: 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

Further study details as provided by Vidacare Corporation:

Primary Outcome Measures:
  • Adequate CT image [ Time Frame: at time of CT examination average time is within 24 hours ] [ Designated as safety issue: No ]
    ability to effectively administer the contrast medium needed for the indicated CT examination.

  • number of participants with adverse events within 24 hours of CT exam [ Time Frame: within 24 hours of CT exam ] [ Designated as safety issue: Yes ]
    incidence of complications assocated with the administration of contrast medium through the intraosseous route.

  • number of participants with adverse events within 30 days of CT exam [ Time Frame: within 30 days of CT exam ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Sponsors and Collaborators
Vidacare Corporation
Investigators
Study Director: Thomas Philbeck, PhD Sponsor Company- Vidacare Corporation
  More Information

No publications provided

Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01531686     History of Changes
Other Study ID Numbers: 2011-02
Study First Received: February 3, 2012
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vidacare Corporation:
intraosseous vascular access
CT examination

ClinicalTrials.gov processed this record on October 23, 2014