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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients whose access point is other than antecubital fossa
结局指标
主要结局
Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
时间窗: at the time of CT scanning
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.
Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta
时间窗: at the time of CT scanning
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.
Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta
时间窗: at the time of CT scanning
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.
Image Quality as Assessed by Rating Scale
时间窗: at the time of CT scanning
Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.
次要结局
- Peak Contrast Infusion Pressure(at the time of CT scanning)
- Injection Flow Rate(at the time of CT scanning)
研究者
Joseph P Hasapes
Assistant Professor
The University of Texas Health Science Center, Houston