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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Contrast Enhanced Computed Tomography

Intervention / Treatment
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* Device: 20GA BD Nexiva Diffusics
* Device: 18GA Conventional Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 Gauge BD Nexiva Diffusics<br>During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch). | Device: 20GA BD Nexiva Diffusics<br>* 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.<br>* Other names: 20G x 1 inch BD Nexiva™ Diffusics™ IV catheter (#383592);|
| Active Comparator: 18 Gauge Conventional Catheter<br>During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the non-fenestrated 18GA Conventional Catheter (18 GA x 1.25 inch Smiths Medical Jelco® IV Catheter). | Device: 18GA Conventional Catheter<br>* 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.<br>* Other names: 18G x 1.25 inch Smiths Medical Jelco® IV Catheter (cat#4055);|
| Experimental: BD Nexiva Diffusics - Nonrandomized<br>Subjects whose veins were not suitable for an 18 GA IV Catheter were assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the fenestrated 20GA BD Nexiva Diffusics single port IV catheter (20GA x 1.00 inch) | Device: 20GA BD Nexiva Diffusics<br>* 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.<br>* Other names: 20G x 1 inch BD Nexiva™ Diffusics™ IV catheter (#383592);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptable Image Quality | Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by: The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and, the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type. In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority. | at the time of image assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Pressure Alarm | The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded. | immediately after contrast injection | 
| Catheter Dislodgement | The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection. | Immediately following power injection | 
| Catheter Transfixation | The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection. | immediately after power injection | 
| Catheter Integrity Failure | Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub. The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection. | immediately after power injection | 
| Automatic Injection Shutoff | The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred. | immediately after contrast injection | 
| Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects | Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified. | at the time of image assessment | 
| 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) | Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified. | at the time of image assessment | 
| 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) | Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified. | at the time of image assessment | 
| Maximum Flow Rate | Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol. | immediately after power injection | 
| Catheter Insertion Success | Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter. The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study. | immediately after catheter insertion | 
| Extravasation of Contrast Media | The number of subjects who experienced injections with extravasation of contrast media is reported. | upon contrast injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CECT, catheter, contrast