Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units - a Bicentric, Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Total ventilation time during intensive care unit stay.
研究概览
简要总结
This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.
详细描述
During the weaning process vigilance, pulmonary mechanics and respiratory drive of the patient are changing. Consequently, ventilation settings have to be modified very often. The modifications can be conducted either according to a weaning protocol or automatically by an expert system (SmartCare/PS). This trial compares protocol-guided weaning with automatic weaning in post-surgical patients and examines the effect on total ventilation time, numbers of manipulations and alarms of the ventilator, length of stay in the ICU and in the hospital, 28- and 90-day mortality.
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
- •Intubated or tracheotomised patients requiring mechanical ventilation at 9:00 am for longer than 9 hours (within this time period invasive and non-invasive ventilation is permitted)
排除标准
- •Cerebral trauma / surgery
- •Age < 18 years
- •Do-not-resuscitate-order
- •Duration of mechanical ventilation > 24 h
- •Patient is currently participating in this trial (including 90 days follow-up period)
结局指标
主要结局
Total ventilation time during intensive care unit stay.
次要结局
- Number of ventilator manipulations during invasive mechanical ventilation
- 28-day and 90-day mortality
- Time in the zone of respiratory comfort during invasive mechanical ventilation
- Number of ventilator alarms during invasive mechanical ventilation
- Length of ICU and hospital stay