The Utility of Lung Clearance Index in Ethnic Groups and in Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Normative values in healthy children
研究概览
简要总结
Introduction:
Non-CF, non-PCD bronchiectasis in children is a chronic, suppurative lung disease diagnosed by high resolution computed tomography (HRCT) imaging of the lungs. Spirometry can be abnormal in bronchiectasis but has been shown to be insensitive to early disease in other related conditions such as cystic fibrosis. Lung clearance index (LCI) could have a role in assessment of the disease.
Lung clearance index is calculated from multiple breath washout tests. There are limited data on the normative values expected using some devices, in a range of ages, and between ethnic groups.
The investigators aim to establish normative values in children aged between 6 years and 12 years, to investigate differences between ethnic groups, and to establish the relationship between lung clearance index and other measures of disease in children with bronchiectasis.
Methods:
Healthy children will be recruited from a range of settings and reviewed to ensure no previous lung disease. Children with bronchiectasis diagnosed on HRCT will be recruited from the outpatient service of Birmingham Children's Hospital.
All participants will perform lung function tests including LCI and spirometry. Basic demographic data was collected.
详细描述
Rationale / Hypothesis:
Hypothesis 1
Having established normative ranges helps support interpretation of lung function testing which is key to their value as an investigation. With LCI, it is important to understand the difference that may be expected between children
of different ethnic backgrounds (as demonstrated with other, non-LCI measures of lung function, where important differences between different ethnic groups has been found).
LCI is calculated from an internally adjusted measure of an individual subject's lung volume, therefore potentially negating inherent differences in ethnic variation.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children
排除标准
- •Those with underlying respiratory/systemic disease/ prematurity
结局指标
主要结局
Normative values in healthy children
时间窗: 24 months
The normative range of measurements of lung clearance index will be determined
次要结局
未报告次要终点