Establishment of Spirometric Predicted Values in Bolivia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- FEV1
研究概览
简要总结
There is no local predicted values for spirometry available in Bolivia. The aim of the present study is to establish moderne predicted values for healthy non-smokers recruited in a major city of Bolivia, Santa Cruz De La Sierra.
详细描述
There is no local predicted values for spirometry available in Bolivia. To establish the predicted spirometric normal values in Bolivia, 500 healthy men and women, non-smokers will be recruited to perfom spirometry using following the actual ATS/ERS 2005 guidelines.
The spirometer is a Bodybox 5500 (Medisoft, Belgium). The tests will be performed by a highly-trained pneumologist, Dr A. Ajata.
Anthropometric variables recorded: age, sex, weight, standing and sitting height.
Spirometric variables recorded: FEV1, FVC, PEF, FEV6, FEF25,50,75 and MEF Statistical anaysis will be done using R and SPSS softwares. Predicted equations will be compared with existing ones, especially the new GLI-2012 predicted equations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
subjects will be assigned to their inclusion number
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy and non-smokers
排除标准
- •unhealthy smokers
- •subjects unable to understand/sign informed consent unable to understand/perform spirometric measurements
研究组 & 干预措施
spirometry
single spirometry: only a routine diagnostic test
干预措施: spirometry (Diagnostic Test)
结局指标
主要结局
FEV1
时间窗: measurements done one time at recruitment during spirometry
Forced expiratory volume in one second (Liter)
FVC
时间窗: measurements done one time at recruitment during spirometry
forced vital capacity (Liter)
FEV1/FVC ratio
时间窗: measurements done one time at recruitment during spirometry
FEV1/FVC ratio , %
次要结局
- Standing height(measurements done one time at recruitment just before spirometry)
- seated height(measurements done one time at recruitment just before spirometry)
研究者
Giuseppe Liistro
Head of clinics
Cliniques universitaires Saint-Luc- Université Catholique de Louvain