Optical Pressure Ulcer Study: Tissue Vascular Optics and Impedance Measurements for the Detection of Early Tissue Damage and Pressure Ulceration
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Spectrometry
研究概览
简要总结
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The investigators would like to see whether non-invasive measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk of it happening.
详细描述
Pressure ulcers are common, distressing and expensive. Currently scoring systems and checks by nursing staff are carried out to assess a patient's risk of developing a pressure ulcer.
The aim is to investigate whether non-invasive physiological measurements can be taken from patients to predict who might be at risk of pressure ulcers to allow us to intervene and reduce the risk.
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
- 是
入选标准
- •HEALTHY VOLUNTEERS:
- •Able to give consent
- •Male or female
- •Over the age of 18 years
- •No known peripheral vascular disease
- •No known tissue damage
- •Able to read and understand basic English language
- •Able to give consent
- •Male or female
- •Over the age of 18 years
- •Either at risk (Braden scale <17) or confirmed Category 1 or 2 PU or confirmed DTI
- •Well enough to attend lab without any attachments (IV fluids, IV medications, oxygen)
- •Able to transfer to bed with assistance of one
- •Able to read and understand basic English Language
排除标准
- •HEALTHY VOLUNTEERS:
- •Presence of tissue damage or ulceration in the foot
- •Known peripheral vascular disease
- •Known hypersensitivity to fixation tape
- •Presence of a pacemaker
- •Participants unable to or refusing to give informed consent
- •Known hypersensitivity to fixation tape
- •Participants unable to or refusing to give informed consent
- •Unable to transfer to bed with assistance of one.
- •Requiring more than routine observations and requiring attachments (IV fluids, IV medications, oxygen)
- •Presence of a pacemaker
结局指标
主要结局
Spectrometry
时间窗: 20 minutes
Light spectrometry to assess tissue oxygen saturation of the heel
Laser Doppler Flowmetry
时间窗: 20 minutes
Laser light to assess perfusion of heel
Impedance
时间窗: 5 minutes
Measurement of oedema of the heel
Temperature
时间窗: 5 minutes
Thermal image of heel to assess skin temperature
次要结局
- Co-morbidities(5 minutes)