Vibration Response Imaging (VRI) in Dyspnea Patients Presenting to the ED
Recruitment status was: Recruiting
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department|
- 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). [ Time Frame: Baseline testing at ED presentation ] [ Designated as safety issue: No ]
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 (+,-).
- 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. [ Time Frame: Baseline testing at ED presentation ] [ Designated as safety issue: No ]
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.
- Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD [ Time Frame: Baseline testing at ED presentation ] [ Designated as safety issue: No ]
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.
- 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.) [ Time Frame: Baseline testing and repeated testing after 2 hours ] [ Designated as safety issue: No ]
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.
Biospecimen Retention: None Retained
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2011|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|ED patients presenting with dyspnea|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206621
|United States, Delaware|
|Christiana Care Health System|
|Newark, Delaware, United States, 19718|
|United States, Nevada|
|University of Nevada School of Medicine|
|Las Vegas, Nevada, United States, 89106|
|United States, New York|
|Lincoln Medical and Mental Health Center|
|Bronx, New York, United States, 10451|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Ohio|
|Metrohealth Medical Center|
|Cleveland, Ohio, United States, 44122|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Beilinson Hospital, Rabin Medical Center|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Charles V. Pollack, MD||Pennsylvania Hospital|