FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
研究概览
简要总结
Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population
详细描述
The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.
The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC<0.70) or the lower limit of normal (FEV1/FVC<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 <0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration < LLN. Reference equations used are those of Caucasians from the NHANES III survey.
Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.
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
- •adult smoker suspected of COPD
排除标准
- •unable to perform spirometry
结局指标
主要结局
The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
时间窗: one measurement lasts 10 minutes
see above
次要结局
未报告次要终点
研究者
Giuseppe Liistro
Head of clinic
Cliniques universitaires Saint-Luc- Université Catholique de Louvain