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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 Nexivaâ„¢ Diffusicsâ„¢) 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.
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 Nexivaâ„¢ Diffusicsâ„¢ 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 Nexivaâ„¢ Diffusicsâ„¢ 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 Nexivaâ„¢ Diffusicsâ„¢) and an 18 GA non-fenestrated, intravenous catheter. The 20 GA BD Nexivaâ„¢ Diffusicsâ„¢ 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 Nexivaâ„¢ Diffusicsâ„¢ 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 Nexivaâ„¢ Diffusicsâ„¢ 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 Nexivaâ„¢ Diffusicsâ„¢ IV catheters are not currently used in the Johns Hopkins Outpatient Center, the Sponsor will provide BD Nexivaâ„¢ Diffusicsâ„¢ IV catheters for use during this training and familiarization period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 Gauge BD Nexiva Diffusics | Experimental | 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). |
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| 18 Gauge Conventional Catheter | Active Comparator | 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). |
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| BD Nexiva Diffusics - Nonrandomized | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20GA BD Nexiva Diffusics | Device | 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. |
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Fishman, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | United States |
Subjects whose veins were determined to be unable to accommodate an 18 GA IV catheter, but that could accommodate a 20 GA IV catheter, were not randomized but were assigned to receive the 20 GA BD Nexivaâ„¢ Diffusicsâ„¢ IV catheter (non-randomized cohort).
Subjects were recruited from those referred to the Johns Hopkins Outpatient Center for contrast enhanced computed tomography, or CECT. Subjects were recruited in January and February of 2013.
The Overall Study table summarizes the number of subjects that Started and Completed in each Reporting Group, including the type of CECT procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | 20 GA BD Nexiva Diffusics - Randomized | During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter |
| FG001 | 18 GA Conventional Catheter - Randomized | During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter |
| FG002 | 20 GA BD Nexiva Diffusics - Nonrandomized | Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 20 GA BD Nexiva Diffusics - Randomized | |
| BG001 | 18 GA Conventional Catheter - Randomized | |
| BG002 | 20 GA BD Nexiva Diffusics - Nonrandomized |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority. | One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec. | Posted | Number | percentage of participants | at the time of image assessment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 20 GA BD Nexiva Diffusics - Randomized |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extravasation | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall Jones, MD | Becton, Dickinson and Company | 801 565-2843 | randall_jones@bd.com |
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| 18GA Conventional Catheter | Device | 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. |
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| 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 |
| 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 |
| 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 |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 20 GA BD Nexiva Diffusics - Randomized | |
| OG001 | 18 GA Conventional Catheter - Randomized | |
| OG002 | 20 GA BD Nexiva Diffusics - Nonrandomized |
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| Secondary | 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. | 126 subjects had HU measurements available from abdominal CT imaging. | Posted | Mean | Standard Deviation | Hounsfield Units | at the time of image assessment |
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| Secondary | 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. | 20 subjects had HU measurements available from thoracic CT imaging. | Posted | Mean | Standard Deviation | Hounsfield Units | at the time of image assessment |
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| Secondary | 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. | 54 subjects had HU measurements available from complete chest and abdomen CT imaging. | Posted | Mean | Standard Deviation | Hounsfield Units | at the time of image assessment |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included. | Posted | Mean | Standard Deviation | mL/second | immediately after power injection |
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| Secondary | 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. | All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study. | Posted | Number | participants | immediately after catheter insertion |
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| Secondary | Extravasation of Contrast Media | The number of subjects who experienced injections with extravasation of contrast media is reported. | One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | upon contrast injection |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | immediately after contrast injection |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | immediately after contrast injection |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | Immediately following power injection |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | immediately after power injection |
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| Secondary | 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. | One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis. | Posted | Number | participants | immediately after power injection |
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| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | 18 GA Conventional Catheter - Randomized | 0 | 103 | 0 | 103 |
| EG002 | 20 GA BD Nexiva Diffusics - Nonrandomized | 0 | 33 | 1 | 33 |
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| Unsuccessful after second attempt |
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