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

NCT01206621 | Unknown

• 1 other identifier: DB051
• Study Type: observational
• Target: 530
• Locations: 2 countries
• Sites: 8

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.

Conditions

Dyspnea

Keywords

dyspnea; COPD; CHF; asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  Baseline testing at ED presentation

• Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD

  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.)

  Baseline testing and repeated testing after 2 hours

Study Arms (1)

ED patients presenting with dyspnea

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (8)

Christiana Care Health System

Newark, Delaware, 19718, United States

RECRUITING

University of Nevada School of Medicine

Las Vegas, Nevada, 89106, United States

NOT YET RECRUITING

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

Lincoln Medical and Mental Health Center

The Bronx, New York, 10451, United States

RECRUITING

Metrohealth Medical Center

Cleveland, Ohio, 44122, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

Beilinson Hospital, Rabin Medical Center

Petah Tikva, 49100, Israel

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 18773329 BACKGROUND

• 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.

  PMID: 19085584 BACKGROUND

• 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.

  PMID: 17551264 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Blood drawn for BNP testing

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Charles V. Pollack, MD

  Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles V. Pollack, MD

CONTACT

215-829-7549; cvpollack@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2010-09

Locations

IL (1); US (7)