The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- The amount of MP delivered with each form of invasive ventilation
研究概览
简要总结
Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.
详细描述
Rationale:
Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (ΔP) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator.
Objective:
To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Admitted to one of the participating ICUs;
- •Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube;
- •Expected to be ventilated > 24 hours; and
- •Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation.
排除标准
- •Age under 18 years;
- •No written informed consent;
- •Morbidly obese; and
- •Any contra-indication for use of INTELLiVENT-ASV
研究组 & 干预措施
INTELLiVENT-ASV
Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before.
干预措施: Procedure: INTELLiVENT-ASV (Procedure)
Conventional Ventilation
Use of conventional ventilation during 3 hours with 30 minutes wash-out time before.
干预措施: Procedure: Conventional ventilation (Procedure)
结局指标
主要结局
The amount of MP delivered with each form of invasive ventilation
时间窗: 3 hours per ventilation mode
The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation
次要结局
- Respiratory rate(3 hours per ventilation mode)
- Tidal volume(3 hours per ventilation mode)
- ICU-length and hospital of stay(first 28 days after start of ventilation)
- 28 day-mortality(first 28 days after start of ventilation)
- Driving pressure(3 hours per ventilation mode)
- Duration of ventilation(first 28 days after start of ventilation)
- Pmax(3 hours per ventilation mode)
研究者
Prof. Dr. Marcus J. Schultz
Prof. Dr. Marcus J. Schultz
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)