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

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary:

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.


Detailed Summary:
Sponsor: Deep Breeze

Current Primary Outcome: 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 ]

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 (+,-).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]

    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 ]

    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 ]

    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.


Original Secondary Outcome: Same as current

Information By: Deep Breeze

Dates:
Date Received: September 21, 2010
Date Started: August 2010
Date Completion: June 2011
Last Updated: May 12, 2011
Last Verified: September 2010