ART-3 Pilot: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy in Patients Without ARDS
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean driving pressure between Day 1 and Day 3
研究概览
简要总结
This is a multicenter randomized controlled pilot trial to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without acute respiratory distress syndrome (ARDS).
详细描述
Mechanical ventilation has the potential to produce or worsen alveolar injury. Driving pressure is the difference between plateau pressure and PEEP. Evidence from observational studies suggests that elevated driving pressure is the main independent determinant of ventilator-induced lung injury, however clinical trials are needed to establish whether targeting low driving pressures can improve clinical outcomes in patients without acute respiratory distress syndrome (ARDS).
Thus, ART-3 pilot is a multicenter randomized controlled trial to assess the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients without ARDS. Patients considered to this trial are those in mechanical ventilation for less than 72 hours without diagnosis of ARDS. We will exclude patients with less than 18 years old; contraindication to hypercapnia such as intracranial hypertension or recent acute coronary syndrome; patients in which a high probability of death within 24 hours is anticipated and patients under exclusive palliative care. Eligible patients will be randomized to the driving pressure limited ventilation strategy or conventional strategy (tidal volume of 8 mL/kg of predicted body weight). The primary outcome is driving pressure between days 1 and 3.
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 on invasive mechanical ventilation for less than 72 hours and without diagnosis of ARDS, and no perspective of extubation in 24 hours.
排除标准
- •Less than 18 years old
- •Presence of any contraindication to hypercapnia as suspected or confirmed intracranial hypertension or recent (<7 days) acute coronary syndrome.
- •Patients in which a high probability of death within 24 hours is anticipated.
- •Patients under exclusive palliative care.
研究组 & 干预措施
Driving pressure limited ventilation
Driving pressure limited ventilation (≤13cmH2O)
干预措施: Driving pressure limited ventilation (Other)
Conventional ventilation
Mechanical ventilation with limited tidal volume (8mL/kg of predicted body weight) and plateau pressure (≤30cmH2O)
干预措施: Conventional ventilation (Other)
结局指标
主要结局
Mean driving pressure between Day 1 and Day 3
时间窗: From Day 1 to Day 3 after randomization
次要结局
- Mean driving pressure from day 1 to 7(Days 1 to 7)
- Rate of driving pressure equal or lower than 13 cmH2O(Days 1 to 3 after randomization)
- Mean tidal volume from day 1 to 7(Days 1 to 7)
- Mean plateau pressure from day 1 to 7(Days 1 to 7)
- Mean of severe acidosis (pH <7.1)(Days 1 to 7)
- Rate of investigators adering to study procedures(Days 1 to 7)
- Mean of positive end expiratory pressure (PEEP) from day 1 to 7(Days 1 to 7)
- Lenght of stay in hospital(Patients will be followed during the period of hospital stay, an expected average of 28 days)
- Number of patients with barotrauma(Days 1 to 7)
- Number of mechanical ventilation free days from day 0 to day 28(From day 0 to day 28)
- 28-day survival(From day 0 to day 28)
- Mean static compliance of the respiratory system from day 1 to 7(Days 1 to 7)
- Mean respiratory rate from day 1 to 7(Days 1 to 7)
- Number of patients with other adverse events(Days 1 to 7)
- Lenght of stay in intensive care unit(Patients will be followed during the period of ICU stay, an expected average of 28 days)
- ICU mortality(Patients will be followed during the period of hospital stay, an expected average of 28 days)
- In-hospital mortality(Patients will be followed during the period of hospital stay, an expected average of 28 days)