Intelligent Underwear (IU) Monitors Pressure, Temperature, Perfusion, Humidity, and Oxygenation in Paraplegics
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change of pressure on skin
研究概览
简要总结
Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting.
The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately.
10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.
详细描述
Background of the study:
Pressure injury is a major problem in patients with no or limited mobility and sensation such as paraplegics. One of the main principles to prevent development of pressure injury is to reduce the pressure over certain regions by changing the resting or lying position periodically. Paraplegics who are suffering from loss of sensation in some parts of the body are at high risk because of the missing internal trigger to change the position regularly. Many studies have addressed the personal, social, medical and economic consequences of pressure injuries. Some studies have investigated solutions aiming to reduce the probability of pressure injury development, such as special mattresses or the frequency of moving the patients from one side to the other etc. So far it has not yet been possible to quantitatively and continuously measure the physiological skin parameters, which are essential in the development of pressure injury, over a long period of time. Up to now, long-term studies on paraplegics are limited because there are no suitable measurement devices. Current measurement devices are hard and inflexible and increase the probability of pressure ulcer development in paraplegics by applying external pressure on the tissue. In this project, the applicability of wearable measuring systems, which do not apply external pressure on the tissue, will be evaluated in paraplegics.
Aim of the study:
The goal of the study is to answer the following questions:
- Is wearable technology usable for skin physiology measurements in paraplegics?
- Are the measurements of skin temperature, pressure, humidity, perfusion, and oxygenation reproducible in able bodied individuals?
- Do changes in skin temperature, pressure, humidity, perfusion, and oxygenation differ between paraplegics and healthy subjects?
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women
- •age: 18 - 50 years
排除标准
- •Any sign of pressure ulcer or a history of pressure ulcer on the ischium
- •Acute infection or disease
结局指标
主要结局
change of pressure on skin
时间窗: baseline and 10 minutes later
measuring skin surface pressure with a pressure sensor in the underpants
次要结局
- change in skin temperature(baseline and 10 minutes later)
- change in skin humidity(baseline and 10 minutes later)
- change in skin oxygenation(baseline and 10 minutes later)
- change in skin perfusion(baseline and 10 minutes later)