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

Terminated

• Conditions: Intraosseous Vascular Access Patients Requiring CT Exam

• Registration Number: NCT01531686
• Lead Sponsor: Vidacare Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-13
• Study Start: 2012-03
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of participants with adverse events within 30 days of CT exam	within 30 days of CT exam
Adequate CT image	at time of CT examination average time is within 24 hours	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	within 24 hours of CT exam	incidence of complications assocated with the administration of contrast medium through the intraosseous route.

Trial Locations

Locations (4)

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States

Shands Critical Care Center and Cancer Hospital; 🇺🇸 Gainesville, Florida, United States

Grand Strand Regional Medical; 🇺🇸 Myrtle Beach, South Carolina, United States

Olive View UCLA Medical Center; 🇺🇸 Sylmar, California, United States