A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- •Signed informed consent
- •Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg)
- •Currently using NIV
排除标准
- •Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min)
- •Unstable heart failure
- •Cardiac failure with dehydration
- •Pregnancy/breastfeeding women
- •Pneumothorax/-mediastinum
- •Increased risk of pneumothorax, pneumomediastinum or venous air embolism
- •In the opinion of the investigator, the patient is unsuitable for the study
研究组 & 干预措施
Single centre, single arm
Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases.
干预措施: Noninvasive ventilation (Device)
结局指标
主要结局
Visual Analogue Scale
时间窗: 1 day
Subjective rating of comfort during expiration
次要结局
- Respiratory rate(1 day)
- Tidal volume(1 day)
- pO2 arterial (paO2)(1 day)
- Minute ventilation(1 day)
- CO2 transcutaneous (tcCO2)(1 day)