Intraosseous Vascular Access Patients Requiring CT Exam Clinical Trial
Official title:
An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
| Verified date | December 2016 |
| Source | Vidacare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | January 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Shands Critical Care Center and Cancer Hospital | Gainesville | Florida |
| United States | Grand Strand Regional Medical | Myrtle Beach | South Carolina |
| United States | Maricopa Medical Center | Phoenix | Arizona |
| United States | Olive View UCLA Medical Center | Sylmar | California |
| Lead Sponsor | Collaborator |
|---|---|
| Vidacare Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adequate CT image | ability to effectively administer the contrast medium needed for the indicated CT examination. | at time of CT examination average time is within 24 hours | No |
| Primary | number of participants with adverse events within 24 hours of CT exam | incidence of complications assocated with the administration of contrast medium through the intraosseous route. | within 24 hours of CT exam | Yes |
| Primary | number of participants with adverse events within 30 days of CT exam | within 30 days of CT exam | Yes |