Diagnosing Respiratory Disease in Children Using Smartphone Recordings of Cough Sounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,245
- 试验地点
- 3
- 主要终点
- Diagnosis of pneumonia
研究概览
简要总结
The purpose of this prospective study is to evaluate the efficacy of the ResAppDx software application in diagnosis of pneumonia and other respiratory conditions (bronchiolitis, asthma/reactive airway disease, croup, upper or lower respiratory tract infections) in infants and children. Patient's cough sounds will be recorded using a smartphone and analysed using the ResAppDx software. The ResAppDx diagnosis will be compared to radiologic diagnosis and/or clinical diagnosis. The ResAppDx diagnosis will not be provided to the clinician or patient.
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
- 29 Days 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant or child aged 29 days - 12 years
- •Presenting to the study site with signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, abnormal lung sounds on exam, cyanosis/hypoxemia.
- •Coughing spontaneously or able to cough voluntarily
排除标准
- •Lack of a signed consent form from parent or legal guardian
- •Lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state.
- •Need for mechanical ventilatory support (including invasive, continuous positive airway pressure, or bilevel positive airway pressure) or high flow nasal cannula
- •Any medical contraindication to voluntary cough, including (only enrolled if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month, or too medically unstable to participate in study per treating clinician.
- •Subject previously enrolled
- •Tracheostomy present or tube placed
结局指标
主要结局
Diagnosis of pneumonia
时间窗: 6 months
Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a radiologic diagnosis. Positive percent agreement and negative percent agreement to diagnose and rule out pneumonia as compared with a clinical diagnosis.
次要结局
- Diagnosis of other childhood respiratory diseases(6 months)