Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Compliance with NIV according to NIV initiation setting in patients with ALS
研究概览
简要总结
This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALS diagnosed by a neurology and
- •chronic respiratory insufficiency or significant respiratory muscle weakness caused by ALS
排除标准
- •impaired cognition to give informed consent to participation
- •contraindication to NIV therapy
- •another severe disease with a prognosis of less than one year
- •ventilation via an artificial airway, tracheostomy
研究组 & 干预措施
NIV initiation in outpatient clinic in patients with ALS
Starting the NIV at the outpatient clinic
干预措施: NIV initiation in patients with ALS (Other)
NIV initiation in pulmonary ward in patients with ALS
Starting the NIV in the pulmonary ward
干预措施: NIV initiation in patients with ALS (Other)
结局指标
主要结局
Compliance with NIV according to NIV initiation setting in patients with ALS
时间窗: 5 years
Association between the initiation method and the patients' compliance with the goal of using NIV more than 4 hours per day.
NIV usage hours according to different initiation locations in patients with ALS
时间窗: 5 years
NIV daily usage hours in the 3-month control after initiation (determined over the preceding month)
Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation.
时间窗: 5 years
The effectiveness of the treatment on the reduction of blood carbon dioxide pressure
次要结局
未报告次要终点
研究者
Heidi Rantala
Consultant
Tampere University Hospital