A Comparative Single Centre Study Assessing the Relationship Between Acoustic Breath Sounds as Measured by a Commercially Available Sound Recording Device Against Standard of Care (Spirometry) in the Assessment of Airflow Obstruction in Patients Who Plan to Undergo Spirometry Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- FEV1
研究概览
简要总结
The goal of this clinical trial is to assess whether wheeze as assessed by a commercially available wheeze monitor is comparable to lung function as measured during a spirometry test. The main questions it aims to answer are whether measures of airflow obstruction (FEV1, FEV1/FVC, PEF) correlate with wheeze score (Tw/Ttot%).
Participants consenting to take part will undergo wheeze measurement prior to and during a spirometry test and will be asked to complete a series of symptom questionnaires.
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
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
- •Consenting adult (aged 18-95) University Hospitals Birmingham patient's attending the Lung Function and Sleep Department (LF&S) routinely as part of their standard clinical management pathway for Lung Function testing that includes Spirometry assessments.
- •All patients irrespective of condition will be approached to participate.
排除标准
- •Subjects who are contraindicated to perform spirometry on the day of testing
- •Subjects who cannot speak or read English
- •Patients accessing non-adult services
- •Subjects who are unable or do not wish to consent
- •Patients with known or suspected restrictive lung disease
结局指标
主要结局
FEV1
时间窗: Day 1
Wheeze score (Tw/Ttot%)
时间窗: Day 1
The average proportion of each breath that contained wheeze during a 30 second breath sound recording.
FEV1/FVC
时间窗: Day 1
the ratio between forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC)
次要结局
未报告次要终点