Pilot Study of Wearable Electronic Breath Sound Sensing Device for Monitoring of Breath Sounds in Pediatric Patients With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Clinical Respiratory Score (CRS) change
研究概览
简要总结
This study will assess the ability of a wearable stethoscope to monitor wheezing in high-risk asthma patients admitted at Children's Healthcare of Atlanta.
This study is important to assist in the health management of patients with chronic lung diseases that can experience exacerbations leading to their health worsening and requiring hospitalization. The population that will be approached for this study will include 10 pediatric subjects hospitalized at Children's Healthcare of Atlanta for an asthma-related exacerbation. Participants will wear the patches for up to 8 hours on their chest and back wall from their date of consent until their hospital discharge. This may range from the participant taking part in 1 to 14 visits that could last up to 8 hours.
详细描述
The main goal of this study is to evaluate the ability of a novel wearable breath sound sensor (wearable stethoscope) to continuously monitor breath sounds, specifically wheezing, in pediatric asthma patients during hospital admission. The data collected will be used to develop a wheeze detection algorithm. The breath sound recordings from this device will not be used for any medical decision-making or treatment changes, and all study participants will continue to receive routine medical management per standard of care guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-17 years
- •Diagnosis of persistent asthma
- •Being treated for an acute asthma exacerbation
- •Parent can speak and understand English
排除标准
- •Unable to provide consent for the study
- •History of prematurity
- •History of other chronic lung conditions - cystic fibrosis, bronchiectasis, or primary ciliary dyskinesia
- •History of latex allergy or allergy to medical tape adhesive
- •Patients currently using another medical device - implanted pacemaker or vagal nerve stimulator or diaphragm pacing device
结局指标
主要结局
Clinical Respiratory Score (CRS) change
时间窗: Star of each recording session, end of each recording session up to 14 days
CRS is a 12-point assessment used to evaluate respiratory distress in hospitalized patients and guide treatment for asthma and bronchiolitis. It measures factors such as respiratory rate, work of breathing, wheezing, hypoxia, dyspnea, and cough. The change in CRS score will be recorded at the beginning and end of each session and later correlated with changes in breath sound recordings from the device. The absolute change in CRS will be correlated with changes in the breath sound recordings.
次要结局
- Detection of wheezing sounds by the wearable stethoscope(Throughout study participation until hospital discharge (up to 14 days))
- Visual Erythema Assessment Scale (VEAS)(At the end of each recording session up until hospital discharge (up to 14 days))
研究者
Lokesh Guglani
Associate Professor
Emory University