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

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

Study Overview

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

Detailed Description

intraosseous vascular access in the proximal humerus can be used to delivery contrast dye 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
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients that have received intraosseous vascular access as standard of care and require CT examination

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
number of participants with adverse events within 30 days of CT exam		within 30 days of CT exam

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 (ESTIMATE): February 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

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