Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome measures from spirometry tests (1)
研究概览
简要总结
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry
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
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children aged 5 to 16 years old
- •Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
- •Child able to perform reliable spirometry
- •Family have access to a smartphone or tablet and a second device for video consultation
排除标准
- •Significant learning difficulties
- •Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
- •Informed consent/assent has not been provided
- •No English speaking member of the family
- •Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)
结局指标
主要结局
Outcome measures from spirometry tests (1)
时间窗: Within two weeks
The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Length of each standard test
时间窗: Within two weeks
Researchers will record how long each standard test took to carry out.
Outcome measures from spirometry tests (2)
时间窗: Within two weeks
The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
次要结局
未报告次要终点
研究者
Heather Elphick
Professor Heather Elphick
Sheffield Children's NHS Foundation Trust