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

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: Dyspnea

• Study Type: Observational
• Enrollment (Anticipated): 530

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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).	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

Collaborators and Investigators

• Sponsor: Deep Breeze
• Investigators: Principal Investigator: Charles V. Pollack, MD, Pennsylvania Hospital

Publications and helpful links

General Publications

• Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
• Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.
• Wang Z, Bartter T, Baumann BM, Abouzgheib W, Chansky ME, Jean S. Asynchrony between left and right lungs in acute asthma. J Asthma. 2008 Sep;45(7):575-8. doi: 10.1080/02770900802017744. Erratum In: J Asthma. 2009 Oct;46(8):859. Baugmann, Brigitte M [corrected to Baumann, Brigitte M]. J Asthma. 2009 Sep;46(7):750. Baumman, Brigitte M [corrected to Baugmann, Brigitte M].

Study record dates

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: COPD; asthma; CHF; dyspnea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: DB051