A Laboratory Trial to Investigate the Biomechanical and Physiological Responses to Prolonged Lying Postures During CLP When Combined With Pulsation Therapy on Caylis Pro® Low Air Loss (LAL) System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Arjo AB
- 入组人数
- 20
- 主要终点
- This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market.
研究概览
简要总结
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
详细描述
This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market (Caylis Pro® LAL System).
A secondary aim is to compare the frequency and amplitude of different pulsation modes with respect to the biomechanical and physiological responses at the participant-support surface interface.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85
- •Healthy male or female
排除标准
- •Systemic skin disease
- •History of pressure ulcers in the sacrum or heels
- •Long term steroid use
- •Inability to maintain lying posture for prolonged periods
研究组 & 干预措施
1 study 2 separate session
The healthy volunteers will be placed on a new mattress which has continuous low pressure (CLP and a pulsatio feature) and during that time period different measurements will be taken.
干预措施: CLP and pulsation (Device)
结局指标
主要结局
This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market.
时间窗: Day 1 and 2
* Comfort, support and firmness scores (using a 7 point verbal rating scale ) * Interface pressure distribution (ForeSitePT, XSensor) * Transcutaneous gas levels * Microclimate measures between the participant and the support surface using temperature and humidity sensors (Sensiron SH75). * Internal Mattress air pressures
次要结局
未报告次要终点