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

February 9, 2026 updated by: Vidacare Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adequacy of Computed Tomography (CT) Image
Time Frame: at time of CT examination average time is within 24 hours
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
Time Frame: at time of CT examination average time is within 30 minutes
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vidacare Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Thomas Philbeck, PhD, Sponsor Company- Vidacare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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