Continuous Registration of Bioimpedance During Hemodialysis
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of patch performance
研究概览
简要总结
This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.
详细描述
The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.
The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.
After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for hemodialysis
排除标准
- •Acute in-current disease.
- •Known adverse reaction to medical adhesive
结局指标
主要结局
Sensitivity and specificity of patch performance
时间窗: August - December 2019
Establish sensitivity and specificity of patch performance relative to extracted water, weight change and blood sample results
次要结局
未报告次要终点