NCT02735135撤回不适用
Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Peak interface pressures at the sacral area (mmHg)
研究概览
简要总结
The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area.
详细描述
The secondary objectives of the study are to compare the two devices in terms of:
A. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 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
- •The patient spends more than 12 hours in bed and verticalisation is possible
- •The patient has a stable medical condition (no complication in the last 10 days) and no visible pressure ulcers
- •The patient is at risk for pressure ulcers as assessed by a score ≤ 15 on the Braden Scale
- •The patient weighs less than 120 kg
排除标准
- •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
- •The subject has a contra-indication for a strictly supine position
- •The patient has a knee flexion deformity > 10 °
- •The patient is in a state of agitation or refuses to cooperate
- •The patient's weight is greater than 120 Kg
- •The length of stay is less than one month
结局指标
主要结局
Peak interface pressures at the sacral area (mmHg)
时间窗: Day 1
次要结局
- Self-assessment for noise (Likert scale)(Month 1)
- Self-assessment of sleep quality (visual analog scale)(Month 1)
- Pressure ulcer development (yes/no)(Month 1)
- Self-assessment of comfort by the patient (visual analog scale)(Month 1)
- Body contact surface area (cm^2)(Day 1)
- Peak pressure at the heel area (mmHg)(Day 1)
研究者
研究点 (6)
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