NCT03189654已完成不适用
Noninvasive Ventilation Therapy for the Treatment of Pleural Effusion in Patients With Heart Failure
Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2017年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Amount of pleural effusion
研究概览
简要总结
There are no investigations so far whether an application of positive pressure during non-invasive ventilation might be a therapeutic option for transudative pleural effusion in patients with heart failure. In view of the pathophysiological process with pleural effusion resulting from an increase in intravascular hydrostatic pressure, non-invasive ventilation might provide an improvement.
The aim of the present study is to investigate whether an additional non-invasive ventilation therapy leads to an improved suppression of pleural effusion in heart failure patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 admitted to our hospital on a routine or emergency basis
- •Patients with heart failure according to the current ESC guidelines and chronic pleural effusion with clinical indication for pleurocentesis
- •Non-invasively determined cardiac index of < 2.5 l/min/m²
- •BNP > 300 pg/ml
- •Transudative pleural effusion according to Light criteria
- •Effective pleurocentesis with residual effusion on the side affected of < 500 ml
- •Tolerance of non-invasive ventilation without subjective or objective hemodynamic impairment as verified during a test ventilation
- •No change in drug or other therapy for the duration of the study (5 days)
排除标准
- •Psychological or neurological concomitant disease making an informed consent impossible
- •Pregnancy
- •Pneumothorax or pneumomediastinum
- •Pathologically low blood pressure, particularly associated with intravascular volume depletion
- •Liquor discharge, recent head surgery or trauma
- •Severe bullous lung disease
- •Dehydration
- •Current ventilation therapy
- •Bilateral pleural effusion > 500 ml at the time of enrolment
- •Exudative pleural effusion
结局指标
主要结局
Amount of pleural effusion
时间窗: 5 days
次要结局
- nt-Pro-BNP(5 days)
- NYHA class(5 days)
- Cardiac output(5 days)
研究者
Thomas Bitter
Senior physician
Heart and Diabetes Center North-Rhine Westfalia
研究点 (1)
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