Multiple-breath Washout for Lung Function Testing in Children With Cystic Fibrosis: Predictive for Survival?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Lung clearance index (LCI)
研究概览
简要总结
Retrospective cohort study using routinely collected annual data on lung clearance index (LCI) in combination with clinical data to predict survival in patients with Cystic Fibrosis. The primary study endpoint is the association of LCI with the compound outcome survival or lung transplantation in patients with CF.
详细描述
Retrospective analysis of longitudinal data collected during clinically routine from approximately 200 patients with CF aged 3 years or more between 01.01.1980 and 31.12.2005. The overall aim of this project is to retrospectively assess whether LCI measured for clinical purposes during school age is predictive for survival or lung transplantation in adulthood. For this, the investigators will assess in a systematic way clinically measured LCI and relate them with the compound outcome survival or lung transplantation retrospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated at the Children's Hospital Bern
- •Confirmed CF Diagnosis
- •Age >= 3 years
排除标准
- •Uncertain diagnosis of CF according to current standards
- •Existing written or otherwise documented refusal to participate in research
结局指标
主要结局
Lung clearance index (LCI)
时间窗: Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached
Lung function outcome derived by MBW and the compound Outcomes mortality or lung transplantation
次要结局
- Functional residual capacity (FRC)(Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Forced expired Volume in 1 second (FEV1)(Lung function is collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Body weight(Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Body length(Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Gender(Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Presence of Pseudomonas aeruginosa infection(Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)
- Presence of Staphylococcus aureus infection(Characteristics are collected quarterly until outcome (death or lung transplantation) or end of Study (12/2005) is reached)