Pilot Study for the Evaluation of EzCVP in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Nihon Kohden
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Evaluate the difference between non-invasive CVP measurement at admission and at discharge
研究概览
简要总结
Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission
详细描述
Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter.
Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge, new technology to assess CVP non-invasively using an oscillometric method has been developed. This new technology involves measurement of the enclosed zone central venous pressure (ezCVP), which, in a preclinical study, has been shown to correlate with invasive data.
Additionally, a previous correlation study demonstrated that the ezCVP value can be mathematically adjusted to estimate invasive CVP. The resulting value has been termed CVPNI (CVP Non-Invasive). Most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in CVPNI with medical treatment over the course of hospitalization.
Moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezCVP technology is needed to prove that changes in CVPNI track with these patients' condition during admission and can be useful in their clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Arm circumference of 23 cm to 55 cm
- •Subject admitted to the hospital with acute exacerbation of heart failure, with either reduced or preserved ejection fraction
- •Subject is at risk for readmission (NYHA Functional Classification 2-3)
- •Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written, informed consent
- •ezCVP indicator is high (CVPNI is over 9 mmHg) at admission
- •Subject is willing and able to comply with protocol procedures
- •Subject tested negative for COVID test after admission to the hospital
排除标准
- •Finger and upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff
- •Pregnant (self-reported)
- •Upper extremity DVT (currently being treated)
- •Severe skin disease involving the upper arm(s)
- •Study investigator may exclude patients based on clinical judgement
结局指标
主要结局
Evaluate the difference between non-invasive CVP measurement at admission and at discharge
时间窗: 7 days
Compare CVPNI at time of admission and discharge in clinical unit CVPNI (CVP subscript NI) is a numeric value equivalence of central venous pressure non-invasive measured in mmHg.
Evaluate the difference between non-invasive CVP measurement in right and left arms
时间窗: 7 days
Compare CVPNI (mmHg) for measurements on left and right arm for same subject
次要结局
- Compare changes in CVPNI to changes in KCCQ quality scores(21 days)
- Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects(100 days)
- Evaluate the relationship between CVPNI at discharge and readmission rate(100 days)
- Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization(7 days)