Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission
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.
Study Type
OBSERVATIONAL
Enrollment
65
* Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. * Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). * Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).
Veterans Affairs Hospital
Palo Alto, California, United States
Stanford Medical Center
Stanford, California, United States
Evaluate the difference between non-invasive CVP measurement at admission and at discharge
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.
Time frame: 7 days
Evaluate the difference between non-invasive CVP measurement in right and left arms
Compare CVPNI (mmHg) for measurements on left and right arm for same subject
Time frame: 7 days
Evaluate the relationship between CVPNI at discharge and readmission rate
Compare CVPNI (mmHg) at time of discharge for high ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge
Time frame: 100 days
Evaluate the relationship between CVPNI to clinical parameter weight during hospitalization
Compare CVPNI changes (∆ mmHg) for high ezCVP subjects during hospitalization to change in measured weight (∆ g)
Time frame: 7 days
Compare changes in CVPNI to changes in KCCQ quality scores
For each of the 3 Kansas City Cardiomyopathy Questionnaire (KCCQ) totals (integer number with no unit of measure): 1. Overall summary score; 2. clinical summary score; 3. symptom stability score: calculate: ∆KCCQ = KCCQ@14 days - KCCQ@admission. Count number of subjects in each group: ABSOLUTE(∆KCCQ) \< 6 (no significant change); ∆KCCQ \>= 6 (significant change improvement); ∆KCCQ \<= -6 (significant change worsening). Compare to ∆CVPNI (unit = mmHg) = CVPNI-mean@admission - CVPNI-mean@discharge. Count number of subjects in each group: ∆CVPNI \<= 0 (no improvement or worsening); ∆CVPNI \> 0 \& \< 5 (improvement); ∆CVPNI \> 5 (large improvement).
Time frame: 21 days
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Evaluate the relationship between CVPNI and readmission rate for low and high ezCVP subjects
Compare CVPNI at time of discharge for high ezCVP subjects versus low ezCVP subjects to subsequent readmission occurrence within 90-100 days post hospital discharge. Readmission is a binary value (true or false).
Time frame: 100 days