Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical utility as assessed by the PI
研究概览
简要总结
Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic testing to admit, follow and discharge patients from hospital. Of these, only auscultation routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown that for more than a decade, readmission after discharge for an exacerbation of COPD or severe asthma (or chronic heart failure) remains a major problem. The Strados System has been designed to extend the range of lung sound recording both geographically and temporally to improve the standard of care when access to continuous monitoring has been replaced by periodic or no monitoring. The primary purpose of this study is to assess the clinical utility of the Strados System in enabling periodic recording and reviewing of breath sounds in patients with chronic respiratory diseases, either in the ICU, or in less continuously monitored settings, including after inpatient discharge.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential study participants will be recruited from within the Einstein Center of Excellence. Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- •Males and females between the ages of 18-80:
- •With documented physician-diagnosed COPD (chronic bronchitis dominant) or severe asthma, as defined either by the American Thoracic Society or the World Health Organization who are admitted for exacerbation, including those with active or suspected SARS-COV-2 infection
- •Who are admitted with respiratory distress symptoms associated with SARS-COV-2 infection
- •Able to provide informed consent
- •Able to follow study procedures
- •Clinician assessment of the patient's current SARS-COV-2 status: negative or unlikely to be infected, RTPCR positive, or untested by clinically suspected
- •Accessible by telephone upon discharge
排除标准
- •Subjects who meet ANY of the following criteria are not eligible for enrollment:
- •Inability or unwillingness of the participant to give written informed consent
- •History of adverse reaction or allergy to Tegaderm
- •Unwillingness or inability to comply with study procedures
- •Scheduled for thoracic procedure
- •Inaccessible by telephone post-discharge
结局指标
主要结局
Clinical utility as assessed by the PI
时间窗: Periodic recording over 12 to 24 hours
To assess the clinical utility of Strados Systems in enabling periodic recording and reviewing of lung breath sounds of inpatients with chronic respiratory diseases in ICU , and less continuously monitored settings.
次要结局
- Correlation of RESP data with other measures of patient status.(Periodic recording over 12 to 24 hours)
- Clinical utility as assessed by other clinicians(Periodic recording over 12 to 24 hours)