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

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

NCT01531686•Vidacare Corporation

View on ClinicalTrials.gov

Summary

An observational study to determine the safety and effectiveness of Intraosseous (IO) vascular access for delivery of contrast dye for Computed Tomography (CT) examination. The hypothesis is that IO access can be safely and effectively used to deliver contrast medium for CT examination.

Detailed Description

An observational study to determine the safety and effectiveness of Proximal Humerus Intraosseous (IO) vascular access for delivery of contrast medium for Computed Tomography (CT) examination. The hypothesis is that Proximal Humerus IO access in conjunction with a pressure-limited power injection device can be safely and effectively used to deliver contrast medium for CT examination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years or older
•Has received intraosseous (IO) vascular access at the proximal humerus insertion site via EZ-IO 45 mm needle set, as standard of care
•Requires Computed Tomography (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 or is obtained from a Legally Authorized Representative (LAR)

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 proximal humerus IO access with an IO catheter other than the EZ-IO 45 millimeter (mm) needle set system
•Has existing proximal humerus IO access using the EZ-IO 45 mm needle set but IO catheter is mal-positioned or dislodged

Locations (4)

Maricopa Medical Center

Phoenix, Arizona, United States

Olive View UCLA Medical Center

Sylmar, California, United States

Shands Critical Care Center and Cancer Hospital

Gainesville, Florida, United States

Grand Strand Regional Medical

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

January 1, 2014

Completion Date

January 1, 2014

Last Updated

February 11, 2026

Enrollment

ACTUAL participants

Conditions

Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam

Interventions

Intraosseous delivery of CT contrast dye

PROCEDURE