NCT05661422撤回不适用
Spectrographic and Acoustic Analysis of Lung Sounds Collected by RESP™ Biosensor to Support of Cardiorespiratory Therapeutic Decision Making in Monitored Hospitalized Pediatric Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Qualification and verification of lung sounds in pediatric population using RESP Biosensor
研究概览
简要总结
This observational clinical trial is designed to confirm whether RESP™ Biosensor could be deployed to support clinical decision making in challenging pediatric cases, minimize clinician-to-clinician variability in lung sound interpretation, obviate the need to disrupt change of shift or chart rounds with physicians, and create a durable archive of the patient's lung sounds for longitudinal comparison within or across hospitalizations.
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
- •Children between the ages of 4 and 17 with documented physician-diagnosed respiratory disease including infection such as RSV or COVID
- •Hospitalization projected for at least 24 hours after device placement
- •Patient and parent/guardian able and willing to provide informed consent/assent.
排除标准
- •Patient and parent/guardian unable or unwilling to provide informed consent
- •Patient expected to undergo prolonged invasive radiology procedure(s)
- •Plan for discharge within 24 hours
- •Patient expected to undergo major thoracic surgery
- •History of adverse reaction or allergy to TegaDerm ® or similar product
结局指标
主要结局
Qualification and verification of lung sounds in pediatric population using RESP Biosensor
时间窗: Periodic recording over 24 hours for inpatient stay
次要结局
- Limitations such as age in pediatric patients(Periodic recording over 24 hours for inpatient stay)
- Acceptability and utilization of RESP Biosensor in clinicians, healthcare staff and patient families(Periodic recording over 24 hours for inpatient stay)
研究者
研究点 (1)
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