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An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye


N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Intraosseous Vascular Access Patients Requiring CT Exam

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Trial Information

An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye


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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Adequate CT image

Outcome Description:

ability to effectively administer the contrast medium needed for the indicated CT examination.

Outcome Time Frame:

at time of CT examination average time is within 24 hours

Safety Issue:

No

Principal Investigator

Thomas Philbeck, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Sponsor Company- Vidacare Corporation

Authority:

United States: Institutional Review Board

Study ID:

2011-02

NCT ID:

NCT01531686

Start Date:

March 2012

Completion Date:

December 2013

Related Keywords:

  • Intraosseous Vascular Access Patients Requiring CT Exam
  • intraosseous vascular access
  • CT examination

Name

Location

Maricopa Medical CenterPhoenix, Arizona  85008
Olive View UCLA Medical CenterSylmar, California  91342
Shands Critical Care Center and Cancer HospitalGainesville, Florida  32608