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

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01206621
• Other study ID #: DB051
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2010
• Last updated: May 12, 2011
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2010
• Source: Deep Breeze
• Contact: Charles V. Pollack, MD
• Phone: 215-829-7549
• Email: cvpollack[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 530
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea

Locations

Country	Name	City	State
Israel	Beilinson Hospital, Rabin Medical Center	Petah Tikva
United States	Lincoln Medical and Mental Health Center	Bronx	New York
United States	Metrohealth Medical Center	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	University of Nevada School of Medicine	Las Vegas	Nevada
United States	Mount Sinai School of Medicine	New York	New York
United States	Christiana Care Health System	Newark	Delaware
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (3)

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. Epub 2007 Jun 4. — View Citation

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. — View Citation

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 Sep;46(7):750. Baumman, Brigitte M [corrected to Baugmann, Brigitte M]. J Asthma. 2009 Oct;46(8):859. Baugmann, Brigitte M [corrected to Baumann, Brigitte M]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No