Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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IV Contrast Administration: Effect of Three Side Hole Infusion Catheter on CT Image Quality, Infusion Pressure, and Infusion Rates, Compared to a Standard Infusion Catheter

Conditions
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Contrast Enhanced Computed Tomography (CT) Scanning

Intervention / Treatment
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* Device: Becton Dickinson Nexiva Diffusics System
* Device: Standard intravenous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing contrast enhanced CT abdomen pelvis examinations at Lyndon B. Johnson General Hospital in Texas Patients whose access point is the antecubital fossa Patients receiving 20 or 22 gauge catheters for their CT exam Patients scanned on two 64 slice CT scanners at the same hospital Exclusion Criteria: patients whose access point is other than antecubital fossa

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Becton Dickinson Nexiva Diffusics System<br>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. | Device: Becton Dickinson Nexiva Diffusics System<br>* 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.<br>|
| Active Comparator: Standard intravenous catheter<br>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. | Device: Standard intravenous catheter<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |