Vibration Response Imaging (VRI) in Dyspnea Patients Presenting to the ED

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department

Conditions
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Dyspnea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide Informed Consent; ->40 years of age; Estimated Body Mass Index >19; Patient presented to the emergency department with a chief complaint of acute dyspnea. Exclusion Criteria: Patients with obvious trauma or acute anxiety as a cause of dyspnea; Patient has already received directed therapy in the ED and symptoms are remarkably improved; Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing; Intubated or mechanically ventilated; Acute hemodynamic or ventilator instability requiring immediate resuscitation; Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); Hirsutism.

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ED patients presenting with dyspnea<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess 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 (+,-). | Baseline testing at ED presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline testing and repeated testing after 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dyspnea, COPD, CHF, asthma