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

NCT ID: NCT01531686

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Intraosseous Vascular Access Patients Requiring CT Exam

Keywords

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intraosseous vascular access CT examination

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Intraosseous delivery of CT contrast dye

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

Intervention Type PROCEDURE

Other Intervention Names

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EZ-IO

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Philbeck, PhD

Role: STUDY_DIRECTOR

Sponsor Company- Vidacare Corporation

Locations

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Maricopa Medical Center

Phoenix, Arizona, United States

Site Status

Olive View UCLA Medical Center

Sylmar, California, United States

Site Status

Shands Critical Care Center and Cancer Hospital

Gainesville, Florida, United States

Site Status

Grand Strand Regional Medical

Myrtle Beach, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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2011-02

Identifier Type: -

Identifier Source: org_study_id