NCT02346305招募中不适用
Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche16 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 16
- 主要终点
- Clinical data leading to NIV device prescription
研究概览
简要总结
The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.
The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.
The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.
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
- •No previous experience with domiciliary non-invasive ventilation
- •Adult patients, ≥ 18 years of age
- •Without tracheotomy
- •No evolutive cancer
- •No significant psychiatric disease
- •Possible medical monitoring
排除标准
- •Evolutive cancer
- •Inability to understand rationale and/or consent form for study
结局指标
主要结局
Clinical data leading to NIV device prescription
时间窗: Day 1
Age, blood gases, BMI, etiology, pulmonary function,comorbidities
次要结局
- Survival rate(2 years)
- Treatment compliance(1 year to 2 years (end of study))
- Change in the possible comorbidities(4 months, 1 year and 2 years after inclusion)
- Hospitalizations(2 years)
- Change in blood gases(4 months, 1 year and 2 years after inclusion)
研究者
研究点 (16)
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