Monitoring of Non-invasive Ventilation During Sleep in ALS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in transcutaneous carbon dioxide and respiratory events
研究概览
简要总结
Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.
Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.
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 with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and
- •symptoms of nocturnal alveolar hypoventilation or
- •increased daytime arterial carbon dioxide partial pressure (PCO2)(> 45 mmHg) or
- •a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value
排除标准
- •Patients < 18 years
- •Patients not willing to start NIV
结局指标
主要结局
Change in transcutaneous carbon dioxide and respiratory events
时间窗: At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months
Search for an optimal titration protocol. Aim is to reduce transcutaneous carbon dioxide (CO2) below 55 mmHg and to reduce central and obstructive respiratory events to a minimum. This will be assessed by performance of a nocturnal measurement of transcutaneous CO2 and full polysomnography at eacht time point.
Change in patient-ventilator asynchronies
时间窗: Day 4 and at 1,3,6,9 and 12 months
The following asynchronies will be evaluated: auto-triggering, double triggering, ineffective effort, prolonged insufflation. The impact of leaks will also be evaluated.Data will be reported as events/hour of sleep. This will be assessed by full polysomnography at each time point.
次要结局
- changes in quality of life by patient reported outcomes(Day 1 and at 1,3,6,9 and 12 months)
- Impact of NIV on sympatho-vagal balance(Day 1 and at 1,3,6,9 and 12 months)
研究者
Dr. Dries Testelmans
MD, PhD
Universitaire Ziekenhuizen KU Leuven