NCT02380820已完成不适用
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6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
- 60
- 试验地点
- 6
- 主要终点
- Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
研究概览
简要总结
The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of 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. contact surface. B. heel pressure. C. On the occurrence of pressure ulcers anywhere on the body at month 1. D. patient comfort after 1 month (visual analog scale ranging from 1 to 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
- 65 Years 至 —（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 with a possible verticalization and a predictable length of stay of at least 1 month.
- •The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers
- •The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale
- •The patient's weight is 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
- •Contra-indication for strict decubitus dorsal position
- •The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane.
- •The patient has bedsores, a recent scar in a pressure area.
- •The patient has a knee flexion deformity> 10 °
- •The patient is agitated or uncooperative
- •The patient's weight is greater than 120 Kg
结局指标
主要结局
Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet
时间窗: Day 1
次要结局
- Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet(Day 1)
- Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet(Day 1)
- Patient-rated comfort as measured by the visual analog scale(1 month)
- Presence/absence of a pressure ulcer over the past month(1 month)
研究者
研究点 (6)
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