NCT05109624已完成不适用
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of complications
研究概览
简要总结
the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- American Society of Anesthesiologists (ASA) physical status II- III.
- •Sex (male and females).
- •Age 18 -80 years.
- •Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
- •mechanical ventilation for less than 36 hours
排除标准
- •- Contraindication for prone positioning
- •increased intracranial tension.
- •face trauma or surgery.
- •Recent Deep venous thrombosis
- •Unstable spine, femur, or pelvic fractures
- •Mean arterial pressure < 65 mm Hg
- •Pregnant women
- •Pneumothorax
- •Prone positioning before inclusion
- •Those returned to supine position before completing the session time
研究组 & 干预措施
group(A) control group
No Intervention
pronation cycles each last for 16 hours every 24 hours
group(B)
Active Comparator
pronation cycles each last for 24 hours followed by 6 hours supine position
干预措施: prolonged prone position ventilation (Procedure)
结局指标
主要结局
Incidence of complications
时间窗: 28 days
Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability
rate of successful weaning
时间窗: 28 days
how many patients successfully extubated, hospital survival, ICU stay
次要结局
- Efficacy of oxygenation(28 days)
研究者
Amr Fouad
lecturer of anesthesia and intensive care
Ain Shams University
研究点 (1)
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