For the patient with acute dyspnea in the ED, early differentiation between CHF and non-CHF causes is essential for proper management. The capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ED and required length of hospital admission. The ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. The VRI technique may provide a quick and accurate method of differentiating between dyspnea due to HF and dyspnea due to pulmonary causes; thereby improving management and outcomes.
Study Type
OBSERVATIONAL
Enrollment
530
Christiana Care Health System
Newark, Delaware, United States
RECRUITINGUniversity of Nevada School of Medicine
Las Vegas, Nevada, United States
NOT_YET_RECRUITINGMount Sinai School of Medicine
New York, New York, United States
RECRUITINGLincoln Medical and Mental Health Center
The Bronx, New York, United States
RECRUITINGMetrohealth Medical Center
Cleveland, Ohio, United States
RECRUITINGPennsylvania Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
NOT_YET_RECRUITINGBeilinson Hospital, Rabin Medical Center
Petah Tikva, Israel
NOT_YET_RECRUITINGAssess the ability of the VRI to improve clinical outcomes via accurate, early classification of the cause of acute dyspnea as HF or other (i.e. COPD, PE etc).
The primary efficacy analysis set (PEAS) consists of all patients who have Gold Standard (GS) diagnosis (CHF/non-CHF) \& VRI records. * Accuracy rate is defined as the accuracy between the GS and VRI. * Accuracy parameters between the GS and VRI will be calculated using accuracy rate, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV) \& likelihood ratios (+,-).
Time frame: Baseline testing at ED presentation
Assess the agreement to aid in classifying the cause of acute dyspnea as HF or other of the VRI in comparison to BNP/NTproBNP assays.
The secondary efficacy analysis set (SEAS) consists of all patients who have final diagnosis (CHF/non-CHF), BNP/NT-proBNP \& VRI results. * Agreement rate (2X2 agreement table) between BNP/NT-proBNP (based on separate decision cut-offs for each assay) and VRI will be calculated for dyspnea due to CHF or other causes. * The discordant observations (from the agreement table) will be further evaluated between the VRI and GS. * Logistic regression will be used in order to find the significance and strength contribution of the VRI and the BNP on the goal-function.
Time frame: Baseline testing at ED presentation
Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD
The tertiary efficacy analysis set (TEAS) consists of all patients who have final diagnosis (CHF/COPD) \& VRI results. -Similar to the previous objectives - accuracy (with the GS) and agreement rates (with BNP/NT-proBNP); comparisons based only on CHF and COPD patients.
Time frame: Baseline testing at ED presentation
Evaluate the ability of the VRI to monitor changes in clinical status following treatment in comparison with other standard testing methods (e.g. ECG, serial chest x-rays, etc.)
The fourth efficacy analysis set consists of patients who have baseline \& after treatment follow-up clinical data \& VRI recordings. * Descriptive statistics will be used in order to evaluate the changes following treatment in comparison to baseline condition. * The changes will be categorized to status of improved, worse or same and will be compared, when available, to existing tools.
Time frame: Baseline testing and repeated testing after 2 hours
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