Clinical trial NCT01772550: Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
Official title: A Randomized Controlled Study to Determine Whether Smaller Gauge Fenestrated Catheters Are as Effective as Larger Gauge Non-fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Enhanced Computed Tomography
Keywords: CECT, catheter, contrast
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2013-01-21
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: This is a prospective study performed in adult human subjects who have been referred for a CECT. The study will occur during a single visit. Once consented and enrolled, subjects whose antecubital veins can accommodate an 18 GA IV catheter (as assessed by the Inserter or designee of the PI), will be randomized to receive either a conventional 18 GA IV catheter (reference, control) or a 20 GA BD Nexiva™ Diffusics™ IV catheter (test). Subjects whose veins are not considered suitable for an 18 GA IV catheter will be placed in a non-randomized cohort for placement of a 20 GA BD Nexiva™ Diffusics™ IV catheter. Subjects will receive one (1) catheter for the study.

The primary objective 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 GA fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter. The 20 GA BD Nexiva™ Diffusics™ IV catheter will be considered non-inferior to conventional 18 GA IV catheters if the 95% upper bound for the difference in percentage of images of acceptable quality between the images acquired using the 18 GA IV catheters and the 20 GA BD Nexiva™ Diffusics™ IV catheters is less than 15%.

Study catheters will be inserted by appropriately licensed healthcare professionals (Inserters). Prior to enrollment, potential Inserters will be trained and qualified by the Sponsor on proper use of the BD Nexiva™ Diffusics™ IV catheter in both an artificial hand model and then in human patients. Inserters will then be expected to use the test product for a period of two (2) weeks, in order to gain familiarity with the product. Because BD Nexiva™ Diffusics™ IV catheters are not currently used in the Johns Hopkins Outpatient Center, the Sponsor will provide BD Nexiva™ Diffusics™ IV catheters for use during this training and familiarization period.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Acceptable Image Quality
timeFrame: at the time of image assessment
Secondary outcomes:
measure: Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects
timeFrame: at the time of image assessment
measure: Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
timeFrame: at the time of image assessment
measure: Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)
timeFrame: at the time of image assessment
measure: Maximum Flow Rate
timeFrame: immediately after power injection
measure: Catheter Insertion Success
timeFrame: immediately after catheter insertion
measure: Extravasation of Contrast Media
timeFrame: upon contrast injection
measure: Automatic Injection Shutoff
timeFrame: immediately after contrast injection
measure: High Pressure Alarm
timeFrame: immediately after contrast injection
measure: Catheter Dislodgement
timeFrame: Immediately following power injection
measure: Catheter Transfixation
timeFrame: immediately after power injection
measure: Catheter Integrity Failure
timeFrame: immediately after power injection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elliot Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References: