Wearable Auscultation Device Validation in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire
研究概览
简要总结
This observational clinical study is an evaluation of a diagnostic tool through comparison. Similar to a validation study, the output of the RESP device will be compared to physician auscultation, surrogated by having an attending pulmonologist listen to blinded recordings.
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
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child aged 4-17 years of age
- •Admitted to Lurie Children's Hospital or the Emergency Department at Lurie
- •Normal breath sounds cohort: (16 patients ages 4-10, 16 patients ages 11-17)
- •Admitted for a non-respiratory complaint
- •Normal breath sounds on screening examination
- •Wheeze cohort: (53 patients ages 4-10, 53 patients ages 11-17)
- •Admitted for pathologic process that may lead to wheezing (e.g., asthma)
- •Presence of wheeze on screening examination
排除标准
- •Children less than age 4, adults (age 18 and above)
- •Patients in the ambulatory setting
- •Unable to provide consent
- •Intubated patients
- •Unstable disease posing a threat to life
- •Adhesive allergy
结局指标
主要结局
Compare the output of the RESP Biosensor System to breath sound interpretation of an attending physician via collected recordings from stethoscope and completion of a comparison questionnaire
时间窗: 12 months
PI will compare Strados RESP portal output with concurrent recordings collected via Littmann 300 Stethoscope. A questionnaire will be used to record and determine similarities and differences between RESP output and Littmann output, ultimately validating the intended use. Spectrographic data and audio recordings obtained via auscultation will be collected respectively by the RESP device and a separate recording stethoscope (Littman CORE Digital Stethoscope) simultaneously. Demographic and clinical data will be collected and stored in REDcap.
次要结局
- Tolerability and usability assessed utilizing The System Usibility Scale to evaluate attitudes towards the use and tolerance of the device by patients and caregivers(12 months)