NCT00927745已完成4 期
Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- gas exchange
研究概览
简要总结
The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients
详细描述
Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days
排除标准
- •ventilation longer than 12 hours prior to inclusion
- •pregnancy
- •inclusion in another study
结局指标
主要结局
gas exchange
时间窗: daily during mechanical ventilation
sedation length
时间窗: ICU discharge
ventilator alarm rates
时间窗: daily during mechanical ventilation
次要结局
- length of mechanical ventilation(ICU discharge)
- ventilator asssociated pneumonia rate(ICU discharge)
- SOFA score(daily during mechanical ventilation)
- death rate(ICU discharge)
- cumulative sedation drugs dosage(ICU discharge)
研究者
研究点 (2)
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