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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Deep Breeze.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT01206621
First received: September 21, 2010
Last updated: May 12, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition
Dyspnea

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deep Breeze:

Primary Outcome Measures:
  • 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 (+,-).


Secondary Outcome Measures:
  • 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

Blood drawn for BNP testing


Estimated Enrollment: 530
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)
Groups/Cohorts
ED patients presenting with dyspnea

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206621

Contacts
Contact: Charles V. Pollack, MD 215-829-7549 cvpollack@gmail.com

Locations
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19718
Contact: Barbara Davis, RN, BSN     302-733-4189     bdavis@christianacare.org.org    
Principal Investigator: Jason T. Nomura, MD            
United States, Nevada
University of Nevada School of Medicine Not yet recruiting
Las Vegas, Nevada, United States, 89106
Contact: David E Slattery, MD     702-383-7885 ext 5     dslatts@mac.com    
Principal Investigator: David E Slattery, MD            
United States, New York
Lincoln Medical and Mental Health Center Recruiting
Bronx, New York, United States, 10451
Contact: Muhammad Waseem, MD     718-579-6010     waseemm2001@hotmail.com    
Principal Investigator: Muhammad Waseem, MD            
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Janice Lam     212-824-8078     Janice.Lam@mountsinai.org    
Principal Investigator: Denise Nassisi, MD            
United States, Ohio
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44122
Contact: Julie Nichols, RN     216-957-6488     jnichols@metrohealth.org    
Principal Investigator: Rita Cydulka, MD            
United States, Pennsylvania
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Charles Pollack     215-829-7549     cvpollack@gmail.com    
Principal Investigator: Charles V Pollack, MD            
United States, Texas
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Syed S Ali, MD     713-873-8555     syeda@bcm.tmc.edu    
Principal Investigator: Syed S Ali, MD            
Israel
Beilinson Hospital, Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Zvi Rotenberg, Dr     9723-937-7000     zrotenberg@clalit.org.il    
Principal Investigator: Zvi Rotenberg, Dr            
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Charles V. Pollack, MD Pennsylvania Hospital
  More Information

Publications:

Responsible Party: Merav Gat, VP of Clinical & Regulatory Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT01206621     History of Changes
Other Study ID Numbers: DB051
Study First Received: September 21, 2010
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Deep Breeze:
dyspnea
COPD
CHF
asthma

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013