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

NCT01531686 | Terminated Results

• 1 other identifier: 2011-02
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

intraosseous vascular access; Computed Tomography (CT) examination

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Intraosseous delivery of CT contrast dye PROCEDURE

Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.

Also known as: EZ-IO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (4)

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Olive View UCLA Medical Center

Sylmar, California, 91342, United States

Location

Shands Critical Care Center and Cancer Hospital

Gainesville, Florida, 32608, United States

Location

Grand Strand Regional Medical

Myrtle Beach, South Carolina, 29572, United States

Location

Results Point of Contact

• Title: Tatiana Puga
• Organization: Teleflex

tatiana.puga@teleflex.com

Study Officials

• Thomas Philbeck, PhD

  Sponsor Company- Vidacare Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 13, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2016-12

Locations

US (4)