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
18 Years
N/A
Open (Enrolling by invite only)
Both
Intraosseous Vascular Access Patients Requiring CT Exam
Both
Intraosseous Vascular Access Patients Requiring CT Exam
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 Center | Phoenix, Arizona 85008 |
| Olive View UCLA Medical Center | Sylmar, California 91342 |
| Shands Critical Care Center and Cancer Hospital | Gainesville, Florida 32608 |
