Einfluss Einer Inversen Druckrampe Bei Der Langzeit-Therapie Mit Nicht-invasiver Ventilation Auf Dyspnoe am Morgen Nach Therapie-Ende. Influence of an Inverse Pressure Ramp in the Long-term Therapy Mit Non-invasive Ventilation on Dyspnea in the Morning After Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change of dyspnea level from baseline to 12 weeks
研究概览
简要总结
Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.
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
- •Age ≥ 18 years
- •Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
- •Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters
- •May have co-existing obstructive sleep apnea syndrome
- •Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning
- •Written informed consent for study participation including data protection
排除标准
- •Missing written informed consent for study participation including data protection
- •Contraindication for positive airway pressure therapy
- •Use of the softSTOPP feature before study inclusion
- •Participation in another study, which influences NIV therapy by defining device settings or titration
- •Concomitant oxygen therapy
结局指标
主要结局
Change of dyspnea level from baseline to 12 weeks
时间窗: 12 weeks
Delta value of morning dyspnea from baseline to 12 weeks as measured by the Borg Scale. The Borg Scale ranges from 0 (no perceived dyspnea at all) to 10 (maximum perceived dyspnea).
次要结局
未报告次要终点