Evaluation of Diagnostic Benefit and Feasibility of Using Lung Ultrasound to Diagnose Childhood Pneumonia in Low-resource Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Pneumonia missed by LUS
研究概览
简要总结
Chest X-ray is historically being used as an imaging standard to aid to the diagnosis of childhood pneumonia, however, the evidence does not support it as a perfect imaging tool. As an alternative to CXR, lung ultrasound (LUS) could be used as the imaging of choice in children and studies have demonstrated its good accuracy to diagnose childhood pneumonia. However, most diagnostic studies have used CXR as a reference standard.
In absence of a 'gold standard' approach, there is a risk that large proportion of children with pneumonia and severe pneumonia could be 'missed' if clinicians relied on LUS only.
This research aims to evaluate the diagnostic benefit of LUS in children compared against 'gold standard' diagnosis which is derived based on the clinical information, imaging and laboratory investigations.
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
Care provider performing LUS scans are masked of CXR report and clinical information about he participant, other than the case has WHO defined pneumonia
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of pneumonia. Pneumonia is suspected in a child meeting the WHO case definition of pneumonia, i.e. cough or difficulty breathing associated with fast breathing and/ or lower chest wall indrawing.
排除标准
- •Non-consenting parents.
- •Children who are hospitalized for more than 24 hours.
- •Children treated for pneumonia at the study site within past 4 weeks.
- •Critical patients requiring emergency lifesaving support and parents unable to cooperate to provide consent.
结局指标
主要结局
Pneumonia missed by LUS
时间窗: From enrolment until day-5 follow up
Proportion of children with any pneumonia (severe or non-severe) that would be missed by LUS at initial presentation
Pneumonia missed by CXR
时间窗: From enrolment until day-5 follow up
Proportion of children with any pneumonia (severe or non-severe) that would be missed by CXR at initial presentation
次要结局
- Diagnostic accuracy of LUS(From enrolment to day-5 follow up)
- Diagnostic accuracy of CXR(From enrolment to day-5 follow up)
研究者
Suraj BHATTARAI
Research fellow (WISE programme)
Nagasaki University