KYMA Device: External Measure of Thoracic Fluid and Vital Signs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Validate the ability of externally monitored thoracic fluid content as a measure of HF.
研究概览
简要总结
External measure of thoracic fluid content (TFC) combined with vital signs (HR,respiratory rate(RR), posture and movements) using the technology developed by Kyma Medical Technologies while tracking clinical changes in acute in-hospital and chronic outpatient heart failure patients.
详细描述
This is a prospective, single center, non-randomized study designed to correlate Kyma measurements and in-hospital parameters as well as the changes in TFC and vital signs with clinical changes in the outpatient setting for 60 days post-discharge. The patient and hospital study personnel will be blinded to the Kyma data captured by the device. No intervention will be performed on the patient based on the Kyma device data, this is an observational study.
The goals of the study are:
- Follow thoracic fluid and vital signs in acute, hospitalized heart failure(HF) patients with evidence of volume overload to evaluate this combined parameter in relation to decongestion (time to clear lung auscultation or clearing of congestion on chest x-ray or decrease in BNP by 50%), clinical symptoms, physical exam, and biomarker results.
- Evaluate the relationship between lung decongestion as externally measured and hemodynamic parameters as measured by pulmonary artery catheter in a subset of patients
- Correlate changes in thoracic fluid content and vital signs with clinical changes in the outpatient setting for 60 days post-discharge.
- Evaluate the feasibility of implementing a physician-directed, patient- managed model of diuretic and vasodilator adjustment.
Patients will be approached for enrollment within 24 hours of presentation to the hospital. The Kyma device will be applied to the patient. Data will be automatically collected by the device: TFC will be measured every 30 minutes and vital signs will be measured several times an hour.
Information collected at baseline by the study coordinators will include medications, lab work (CBC, Chemistry, BNP), ejection fraction(EF), weight, vital signs, and lung auscultation for both Cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Men or women over 18 years of age
- •Admitted for primary diagnosis of HF
- •Already assigned for indwelling PA catheter monitoring
- •Two of the following: edema, JVP>7cm, rales
- •Currently being assessed with clinically indicated hemodynamic monitoring
- •Men or women over 18 years of age
- •Admitted with the primary diagnosis of HF
- •Two of the following: edema, JVP> 7cm, rales
- •Patients with or without hemodynamic monitoring in use
排除标准
- •Cohort I and II
- •Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive
- •Pregnant women
研究组 & 干预措施
Cohort I
Patients admitted with the primary diagnosis of HF and are currently being assessed with clinically indicated hemodynamic monitoring.The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected through hemodynamic monitoring. The device will be worn for 60 days post hospital discharge.
干预措施: Kyma Device u-Cor System (Device)
Cohort II
Patients admitted with the primary diagnosis of HF and are being assessed with or without hemodynamic monitoring. The Kyma device will be worn by the patient and data collected from the device will be compared to the data collected while the patient is hospitalized. The device will be worn for 60 days post hospital discharge.
干预措施: Kyma Device u-Cor System (Device)
结局指标
主要结局
Validate the ability of externally monitored thoracic fluid content as a measure of HF.
时间窗: 60 days
Accomplished by comparing the data measured by the Kyma Device(HR, RR, thoracic fluid content) with the same clinical data collected while in the hospital.
次要结局
- Assess the effectiveness of remote monitoring in detecting outpatient decompensation.(60 days)