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

May 12, 2011 updated by: Deep Breeze

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

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Not yet recruiting
        • Beilinson Hospital, Rabin medical Center
        • Contact:
        • Principal Investigator:
          • Zvi Rotenberg, Dr
  • United States
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System
        • Contact:
        • Principal Investigator:
          • Jason T. Nomura, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Not yet recruiting
        • University of Nevada School of Medicine
        • Contact:
        • Principal Investigator:
          • David E Slattery, MD
    • New York
      • Bronx, New York, United States, 10451
        • Recruiting
        • Lincoln Medical and Mental Health Center
        • Contact:
        • Principal Investigator:
          • Muhammad Waseem, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School of Medicine
        • Contact:
        • Principal Investigator:
          • Denise Nassisi, MD
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • Rita Cydulka, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
        • Contact:
        • Principal Investigator:
          • Charles V Pollack, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Syed S Ali, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting to the ED with acute dyspnea who are greater than 40 years of age and consisting of both male and females

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ED patients presenting with dyspnea

What is the study measuring?

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).
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 (+,-).
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.
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.
Baseline testing at ED presentation
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.
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.)
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.
Baseline testing and repeated testing after 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deep Breeze

Investigators

  • Principal Investigator: Charles V. Pollack, MD, Pennsylvania Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

June 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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