Evaluation of Conventional Non-invasive Mechanical Ventilation (NIV) Versus an Automatic Ventilation Mode in Patients With NIV Criteria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Partial pressure of oxygen (PaO2)
研究概览
简要总结
To evaluate the polysomnographic performance of an automatic ventilatory mode compared with the gold standard (manual polysomnographic titration) to adjust chronic non-invasive ventilation by means of a randomized cross-over study.
详细描述
Prospective randomized crossover study in 26 patients with chronic non-invasive ventilation (NIV) criteria, comparing the NIV titration with polysomnography vs an automatic mode of ventilation. It will be compared with clinical parameters of ventilation, blood analysis and inflammation reactants as well as evaluating the patient's comfort after each mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •chronic respiratory failure
- •Diurnal hipercapnia and/or nocturnal hypoventilation (CT90% >10%)
排除标准
- •Under 18 years old.
- •Presence of severe uncontrolled cardiac comorbidity.
- •Impossibility to achieve adaptation to therapy in the training session.
研究组 & 干预措施
MANUAL
Manual titration of non-invasive mechanical ventilation using polysomnography and randomized
干预措施: BIPAP, manual tritration. (Device)
AUTOMATIC
Automatic titration of the non-invasive mechanical ventilation using the same device in an automatic mode with assured volume and pressure support.
干预措施: BIPAP, Intelligent automatic mode defined by assured volume with pressure support (Device)
结局指标
主要结局
Partial pressure of oxygen (PaO2)
时间窗: two weeks
Measure levels after each polysomnography using arterial blood gases
Partial pressure of carbon dioxide (PaCO2)
时间窗: two weeks
Measure levels after each polysomnography using arterial blood gases
次要结局
- Oxygen saving time below 90% (CT90%)(one month)
研究者
CRISTINA EMBID LOPEZ
Principal Investigator
Hospital Clinic of Barcelona