NCT01402765已完成不适用
Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2012年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Percentage of data capture time at < 30 mmHg (%)
研究概览
简要总结
The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Bedridden patients that still have some measure of mobility, or that can change beds with assistance.
- •Patients with symmetrical buttox support
- •Body mass index between 16 and 35
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Strict decubitus dorsal position is contra-indicated
- •State of agigation or non-cooperation
- •Asymetrical deformation of the spine or hips in the frontal plane
- •Bed sores present
- •Evolving cardiac pathology
- •Recent scar at a pressure interface
- •Deep vein thrombosis
- •Expected life span < 24 weeks
结局指标
主要结局
Percentage of data capture time at < 30 mmHg (%)
时间窗: Day 1
Percentage of data capture time with a pressure redistribution index measured at the sacrum and buttox at \< 30 mmHg
次要结局
- Minimum interface pression (mmHg)(Day 1)
- Maximum interface pressure (mmHg)(Day 1)
- Mean interface pressure (mmHg)(Day 1)
- Percentage of data capture time where the pressures are changing (%)(Day 1)
- Matress tolerance: yes/no(Day 1)
研究者
研究点 (2)
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