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

NCT01772550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2014-05-02

Study results available
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Summary

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.

Conditions

  • Contrast Enhanced Computed Tomography

Interventions

DEVICE

20GA BD Nexiva Diffusics

The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm. If the Inserter is unsuccessful in the second attempt, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.

DEVICE

18GA Conventional Catheter

The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm. If after the first attempt, there is no vein in the contralateral arm that can accommodate an 18 gauge catheter, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Elliot Fishman, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772550 on ClinicalTrials.gov