Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress: Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 5
- 主要终点
- percentage of patients who developed at least one stage 2 pressure injury
研究概览
简要总结
The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk.
This study is noncomparative, observational study.
Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department.
Patients are followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patient with a medium to high risk of developing pressure ulcers (clinical judgment and a score of [10 to 14] on the Braden scale (6 (maximum risk) to 23 (no risk))
- •Patient without pressure injury on the day of inclusion
- •Patient up during the day, lying between 3 p.m. and 8 p.m. a day on a Domus 4 / AUTO mattress
- •Patient with a weight < 200 kg
- •Patient (or a trusted third party) having been informed of the study and agreeing to participate
排除标准
- •Patient at end of life (estimated life expectancy less than 6 months)
- •Malnourished patient according to the french health authority (Haute Autorité de la santé) definition*
- •* For adults under 70:
- •weight loss ≥ 5% in one month or ≥ 10% in six months
- •or body mass index (BMI) ≤ 18.5 (excluding constitutional thinness)
- •for adults over 70:
- •weight loss ≥ 5% in one month or ≥ 10% in six months
- •or BMI ≤ 21
- •or Mini Nutritional Assessment (MNA) ≤ 17 (/30)
- •or albuminemia < 35 g/L
结局指标
主要结局
percentage of patients who developed at least one stage 2 pressure injury
时间窗: 35 days after installation on the mattress (at day 35)
Percentage of patients who developed at least one stage 2 PI of the sacrum, backbone, or heel (areas of support when lying down)
次要结局
- Assessment of the degree of maceration(35 days after installation on the mattress (at day 35))
- Percentage of patients who developed a o pressure injury (any stage), other than those of the sacrum, backbone, or heel between(35 days after installation on the mattress (at day 35))
- Assessment by the nursing staff with the use of the mattress (implementation, cleaning maintenance turning, changing to a sitting position)(35 days after installation on the mattress (at day 35))
- Assessment of mattress safety(At day 35)
- Assessment by the patient (or family or staff in the case of incapacity) of the comfort of the mattress (general comfort, stability)(35 days after installation on the mattress (at day 35))