Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans

Completed · Not applicable

Conditions studied: Contrast Enhanced Computed Tomography

In brief

The purpose of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter. In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly deliver contrast agent to an individual's circulatory system. The contrast allows for greater differentiation of tissues in images of the area of interest, affording a better opportunity to visually assess the area and hence make a more accurate diagnosis. CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is required to achieve these high flow rates; however, often the patient does not have a vein that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is designed to deliver a higher flow rate than a conventional catheter of the same gauge by incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to exit the catheter in addition to that which normally exits through the main opening at the tip of the catheter.

Key facts

Study ID: NCT01772550
Run by: Becton, Dickinson and Company
People needed: 238
Starts: 2013-01-01
Expected to finish: 2013-02-01
Last updated by the study team: 2014-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must be at least 18 years old at the time of enrollment,
Must meet the investigational site's standard criteria for multi-detector Computed Tomography (CT),
Per institutional protocol, the ordered scan must require a flow rate of 5.0-7.0 mL/sec (inclusive) for Visipaque 320 or 5.0-7.5 mL/sec (inclusive) for Omnipaque350 warmed to 35°C,
The planned catheter insertion site must be located in the antecubital area,
Must require any of the following multi-detector CT procedures: CT angiogram,CT pancreas,CT liver, CT kidney, Cardiac CT,
Must be willing and able to provide informed consent,
Must be able to read, write, and follow instructions in English,
Must be able to accommodate a 20 G x 1.00 inch IV catheter,

You may not qualify if…

Preexisting IV catheter or contrast-compatible port in place suitable for power injection with the intent to be used for contrast enhanced CT,
Subjects who have reported an adverse reaction that precludes use of iodine-based contrast media,
Subjects who have had a prior extravasation event involving solutions considered irritants or vesicants.

Where it is running

Johns Hopkins Outpatient Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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