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
- 6
- 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
研究组 & 干预措施
ARDSNet strategy
Patients will receive a mechanical ventilation strategy based on fixed values of positive end-expiratory pressure according to inspired fraction of oxygen.
Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.
This arm is similar to the ARMA (Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome) trial.
干预措施: ARDSNet ventilatory strategy (Procedure)
STAMINA strategy
Patients will receive a mechanical ventilation strategy based on positive end-expiratory pressure tailored to achieve the optimal respiratory system compliance and to have driving pressure limited to 14 cmH2O.
Plateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.
干预措施: Positive end-expiratory pressure titration with driving pressure control (Procedure)
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)