Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Use of non-invasive mechanical ventilation
研究概览
简要总结
The purpose of this investigation is to see if outpatient initiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up in patients with amyotrophic lateral sclerosis is non-inferior to initiation during admission to the hospital
The primary hypothesis is that outpatient intiation of noninvasive home mechanical ventilation combined with closed telemonitoring and follow-up is non-inferior to initiation during hospitalization in patients with amyotrophic lateral sclerosis.
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
- Single (Outcomes Assessor)
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
- •Diagnosed with amyotrophic lateral sclerosis
- •Indication for start of non-invasive mechanical ventilation
排除标准
- •No informed consent
- •Does not understand Danish or English
- •Indication for invasive mechanical ventilation
- •No morning baseline PCO2
- •Hospitalization
研究组 & 干预措施
Outpatient
Outpatient initiation of non-invasive mechanical ventilation
干预措施: Outpatient (Other)
Hospitalization
Initiation of non-invasive mechanical ventilation during hospitalization
干预措施: Hospitalization (Other)
结局指标
主要结局
Use of non-invasive mechanical ventilation
时间窗: The 83th to the 90th day after initiation of non-invasive mechanical ventilation
Use of non-invasive mechanical ventilation in minutes per day
次要结局
- Patient satisfaction with the treatment(Measured at the 3 months follow-up visit)
- Patient satisfaction with the proces in relation to the start of the treatment(Measured at the 3 months follow-up visit)
研究者
Anne Kathrine Staehr-Rye
M.D.
Rigshospitalet, Denmark