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

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.

Study Overview

• Status: Terminated
• Conditions: Patients With Intraosseous Vascular Access Requiring Computed Tomography (CT) Exam
• Intervention / Treatment: Procedure: Intraosseous delivery of CT contrast dye

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Sylmar, California, United States, 91342
      • Olive View UCLA Medical Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands Critical Care Center and Cancer Hospital
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Regional Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have received proximal humerus intraosseous vascular access as standard of care via the EZ-IO 45 mm needle set and require Computed Tomography (CT) examination

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of Computed Tomography (CT) Image	Adequacy of CT image graded as adequate or inadequate indicating the ability to effectively administer the contrast medium needed for the indicated CT examination.	at time of CT examination average time is within 24 hours
Incidence of Complication With Administration of Contrast for Computed Tomography (CT) Examination	incidence of complications associated with the administration of contrast through the proximal humerus intraosseous (IO) route for CT examination	at time of CT examination average time is within 30 minutes

Collaborators and Investigators

• Sponsor: Vidacare Corporation
• Investigators: Study Director: Thomas Philbeck, PhD, Sponsor Company- Vidacare Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimated): February 13, 2012

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: intraosseous vascular access; Computed Tomography (CT) examination
• Other Study ID Numbers: 2011-02