A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Leg circumference measured with ESD (mm)
研究概览
简要总结
The purpose of the study is to evaluate a prototype of an intelligent stocking (Edema Stocking Device [ESD]), consisting of two stretch sensitive sensors, as a new method for continuously lower leg volume monitoring. The study is a scientific evaluation of the ESD compared with water displacement volumetry and tape measure.
详细描述
Background:
Balance of body fluids is strictly regulated within a narrow range and is controlled by water movement between the interstitial compartment and the capillaries. An unnatural balance between the two compartments can be seen in several diseases, leading to a net filtration out of the vascular space, resulting in the formation of edema. Monitoring of edema formation represents a unique way of evaluating the degree of the underlying disease and effect of treatment. Numerous different methods can be used to quantify leg volume. However, no current method provides continuous quantitative assessment. The feasibility of continuous lower leg measuring using an intelligent stocking was hypothesized.
The aim of the study was to evaluate the Edema Stocking device (ESD) as a tool for continuous quantification of edema compared with water displacement volumetry (WDV) and tape measure.
Materials and methods
Study design: Non-randomized equivalence study. Experimental comparison study of new method compared to golden standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Edema of the lower legs.
- •Between 20-18 years.
- •Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.
排除标准
- •Length of lower leg of more than 34,0 cm (measured from floor to knee).
结局指标
主要结局
Leg circumference measured with ESD (mm)
时间窗: 60 minutes
Obtained with the Edema Stocking Device
Leg volume measured with ESD (ml)
时间窗: 1 minute
Obtained with the Edema Stocking device
Leg volume measured with WDV (ml)
时间窗: 1 minute
Obtained with water displacement volumetry
Leg circumference measured with tape measure (mm)
时间窗: 1 minute
Obtained with tape measure
次要结局
未报告次要终点
研究者
Alexander Emil Kaspersen
Project manager
University of Aarhus
