Clinical trial NCT01206621: Vibration Response Imaging (VRI) in Dyspnea Patients Presenting to the ED
Official title: Assessment of the Utility of Vibration Response Imaging (VRI) in Evaluating Dyspnea Patients Presenting to the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspnea
Keywords: dyspnea
COPD
CHF
asthma
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2010-09-22
Enrollment: 530
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: Baseline testing at ED presentation
Secondary outcomes:
measure: 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.
timeFrame: Baseline testing at ED presentation
measure: Assess the ability of the VRI to aid in classifying the cause of acute dyspnea as HF or COPD
timeFrame: Baseline testing at ED presentation
measure: 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.)
timeFrame: Baseline testing and repeated testing after 2 hours
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Petah Tikva
country: Israel
facility: Beilinson Hospital, Rabin Medical Center
Study officials:
affiliation: Pennsylvania Hospital
name: Charles V. Pollack, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.