Prospective, Randomized, Controlled Trial Assessing the Effects of a Driving-pressure Limiting STrAtegy for Patients With Acute Respiratory Distress Syndrome Due to coMmunIty-acquired pNeumoniA (STAMINA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 214
- 试验地点
- 8
- 主要终点
- Mechanical ventilation free days
研究概览
简要总结
Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.
详细描述
There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking.
We will perform an open label randomized controlled trial comparing both strategies.
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
- 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
- •Patients with community acquired pneumonia requiring invasive mechanical ventilation
- •Bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician
- •One of the criteria below:
- •Oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmH2O to main peripheral oxygen saturation above 93%, OR
- •Arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with PEEP values of at least 5 cmH2O
排除标准
- •Patients with inclusion criteria for more than 36 hours
- •Refusal of the patient´s legal representative
- •Acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension)
- •Patients with current airway fistula or barotrauma
- •Patients on chronic home use of oxygen due to underlying lung disease
- •Patients younger than 18 years
- •Patients not on full code status
结局指标
主要结局
Mechanical ventilation free days
时间窗: 28 days
Number of days patient remains independent of mechanical ventilation
次要结局
- Need for rescue therapies for refractory hypoxemia(28 days)
- Intensive Care Unit Mortality(90 days)
- Occurrence of barotrauma(28 days)
- Hospital Mortality(90 days)