Comparison of Noninvasive Pulmonary Artery Compliance During and After Decompensation in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
研究概览
简要总结
Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery Compliance measurements will be made daily during the hospital stay. Patients can continue using the device at home for the next 3 weeks. Each patient will serve as their own control and relative changes from their baseline will be recorded for each parameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must ≥ 18 years of age
- •Patient has been diagnosed with Congestive Heart Failure, class II-IV
- •Patient is currently being admitted for decompensation related to Congestive Heart Failure
- •Subject or subject's legally authorized representative is able to give informed consent before entering the study.
排除标准
- •Currently pregnant or breastfeeding
- •Clinical signs or symptoms of a respiratory infection
- •Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment
- •Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator
- •Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
研究组 & 干预措施
CardioSpire Device
Patients blows into Respirix device or uses BIPAP machine for a few breaths solely to obtain signal.
干预措施: CardioSpire (Respirix) Device (Device)
结局指标
主要结局
Diuretics resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
时间窗: Through study completion, up to 1 month depending on readmission
Comparing fluid management (diuretics) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF).
Fluid status based on weight changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
时间窗: Through study completion, up to 1 month depending on readmission
Comparing fluid management (through weight changes) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF).
Vasoactives resulting in fluid status changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
时间窗: Through study completion, up to 1 month depending on readmission
Comparing fluid management (vasoactives) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF).
Clinical congestion measurement changes in severely compensated CHF patients from hospital admit time to discharge and to follow up visit
时间窗: Through study completion, up to 1 month depending on readmission
Comparing clinical congestion measurement (taken as standard of care) to daily CardioSpire's non-invasive Pulmonary Artery Compliance (nPAC) value over the time course from decompensation (at hospital admission) through compensation (discharge) and at their follow up visit, in congestive heart failure patients (CHF).
次要结局
未报告次要终点