Preventive Strategies in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- ARDS development
研究概览
简要总结
The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.
This study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.
详细描述
The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).
- •LIPS > 4 points.
- •Absence of mild, moderate and severe ARDS criteria (Berlin definition).
- •Older than 18 year-old.
- •Signed informed consent
排除标准
- •Bilateral pulmonary infiltrates in chest X-ray at admission.
- •Mechanical ventilation > 12 hours.
- •Previous pneumonectomy or lobectomy.
- •Severe cranial trauma (Glasgow Coma Scale<9) or cranial hypertension.
- •Severe chronic pulmonary disease (GOLD IV).
- •Admission from other hospital under MV.
- •Limitation of therapeutic effort.
- •Pregnancy.
- •Acute pulmonary embolism.
- •Participation in other interventional trials.
- •Previous randomized in the proposed trial.
- •Absence of informed consent.
结局指标
主要结局
ARDS development
时间窗: 7 days
To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.
次要结局
- Mortality(90 days)
- Ventilator-free days(28 days after admission)
- Pneumonia(7 days)
- Dead space(7 days)
- Length of stay(participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks)
- Atelectasis(7 days)
研究者
Antonio Artigas Raventós
Director of Critical Care Arrea
Corporacion Parc Tauli