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The purpose of this research study is to compare two types of catheters used for infusing the contrast dye necessary for viewing internal organs during computed tomography (CT) scanning. The standard catheter, which has one hole from which contrast dye enters veins, will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for diffusing dye into veins. The purpose of this study is to determine which catheter type gives the best image.
This will be a prospective, randomized, controlled trial. The catheter is already in use at our facilities. After informed consent, patients will be randomly given the standard or new catheter in our practice. Envelopes with the random assignment will be available to the individuals consenting patients. Randomization generally ensures that study groups are similar on average. As age, sex, and weight impact image quality, we will collect data on these factors in case randomization results in an imbalance. This will allow for control of these factors in analysis of the data. Data will be collected from CT abdomen pelvis examinations within a 6 month-1 year period in 2016 - 2017. Our primary outcome is image quality, measured as tissue density and distribution of contrast within the liver, spleen, aorta and IVC. Our secondary outcomes include Peak Contrast Infusion Pressure and Injection Flow Rate. Possible adverse events for use of any type of catheter include contrast infiltration into the subcutaneous tissues which is a minor limited event. All infiltrations will be recorded as part of the permanent medical record, documented in the chart, and the referring physician notified. The patient will be assessed by a physician immediately and referred to the ED if necessary for further evaluation. Current technology utilizes Power injector equipment which alerts the technologist to the pressure being achieved. If the injection pressure exceeds 325 psi the Power injector automatically shuts off.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Becton Dickinson Nexiva Diffusics System | Experimental | Intervention with the new Becton Dickinson Nexiva Diffusics System will be evaluated to see if it will improve image quality compared to the standard catheter. |
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| Standard intravenous catheter | Active Comparator | Standard catheter with one hole at the tip will be compared to novel 3 hole Becton Dickinson Nexiva Diffusics System to see which catheter provides the best image quality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Becton Dickinson Nexiva Diffusics System | Device | Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design. |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta | The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | at the time of CT scanning |
| Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta | The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | at the time of CT scanning |
| Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta | The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | at the time of CT scanning |
| Image Quality as Assessed by Rating Scale | Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome. | at the time of CT scanning |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Contrast Infusion Pressure | The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study. | at the time of CT scanning |
| Injection Flow Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Hasapes, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Becton Dickinson Nexiva Diffusics System Fenestrated Catheter | Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard intravenous catheter | Device | Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality. |
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The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
| at the time of CT scanning |
| Standard Intravenous Non-fenestrated Catheter |
The standard catheter has one hole at the tip for contrast infusion. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Becton Dickinson Nexiva Diffusics System Fenestrated Catheter | Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein. |
| BG001 | Standard Intravenous Non-fenestrated Catheter | The standard catheter has one hole at the tip for contrast infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Abdominal anterioposterior diameter at lower kidneys | Mean | Standard Deviation | centimeters |
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| Abdominal transverse (left-right) diameter at lower kidneys | Abdominal transverse (left-right) diameter at lower kidney data was not collected for all subjects. | Mean | Standard Deviation | centimeters |
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| 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 | Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta | The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | Posted | Mean | Standard Deviation | Ratio | at the time of CT scanning |
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| Primary | Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta | The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | Data for the "Becton Dickinson Nexiva Diffusics System fenestrated catheter" arm was not collected for one patient because the patient had a splenectomy. | Posted | Mean | Standard Deviation | Ratio | at the time of CT scanning |
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| Primary | Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta | The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality. | Posted | Mean | Standard Deviation | Ratio | at the time of CT scanning |
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| Primary | Image Quality as Assessed by Rating Scale | Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome. | Posted | Mean | Standard Deviation | units on a scale | at the time of CT scanning |
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| Secondary | Peak Contrast Infusion Pressure | The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study. | Peak contrast infusion pressure data was not collected by the technologist for one patient in the "Standard intravenous non-fenestrated catheter" arm. | Posted | Median | Inter-Quartile Range | Pounds per square inch (PSI) | at the time of CT scanning |
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| Secondary | Injection Flow Rate | The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study. | Posted | Mean | Standard Deviation | milliliters per second (mL/sec) | at the time of CT scanning |
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20 minutes after injection of contrast
Every patient was checked for contrast reaction and infiltration of contrast into the skin.
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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 | Becton Dickinson Nexiva Diffusics System Fenestrated Catheter | Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG001 | Standard Intravenous Non-fenestrated Catheter | The standard catheter has one hole at the tip for contrast infusion. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph P. Hasapes, M.D. | The University of Texas Health Science Center at Houston | (713) 566-5440 | Joseph.P.Hasapes@uth.tmc.edu |
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