A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- number of patients with a new pressure sore of any stage in any predetermined location
研究概览
简要总结
A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •18 years or more in age
- •staying in Intensive Care Unit (ICU)
- •Intubated
- •mechanically ventilated
- •severe ARDS defined as arterial Pressure in Oxygen (PaO2)/ Oxygen Inspired Fraction (FIO2) < 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FIO2 ≥ 0.60
- •prone positioning indicated by the clinician in charge
- •weight < 140 kgs
- •agreement to participate obtained from the confidence person of the patient
- •affiliated to social protection insurance
排除标准
- •contra-indication to the prone positioning
- •prone positioning before inclusion
- •person under legal protection
- •pregnancy
- •weight > 140 kg
- •tracheotomy
- •extracorporeal membrane oxygenation (ECMO)
- •Refusal to participate
研究组 & 干预措施
control period
standard preventive methods of pressure sores in each center
干预措施: standard preventive methods of pressure sores (Procedure)
experimental period
experimental multifaceted preventive methods of pressure sores
干预措施: experimental multifaceted preventive methods of pressure sores (Procedure)
结局指标
主要结局
number of patients with a new pressure sore of any stage in any predetermined location
时间窗: day 7 after inclusion
New pressure sores are validated by the independent committee (2 persons) in charge of the analysis of the pictures performed in the patients. The whole body is pictured in 3 parts and specific locations will be analyzed, which are forehead, nose, eyes, chin, jaw, lips, thorax, breast, knee, iliac crest, foot extension area, and external genitalia in man. For each location a four-stage severity score of the pressure sore is assessed.
次要结局
未报告次要终点