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

NCT ID: NCT01206621

Last Updated: 2011-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dyspnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ED patients presenting with dyspnea

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Breeze

INDUSTRY

Sponsor Role lead

Responsible Party

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Deep Breeze

Principal Investigators

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Charles V. Pollack, MD

Role: PRINCIPAL_INVESTIGATOR

Pennsylvania Hospital

Locations

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Christiana Care Health System

Newark, Delaware, United States

Site Status RECRUITING

University of Nevada School of Medicine

Las Vegas, Nevada, United States

Site Status NOT_YET_RECRUITING

Mount Sinai School of Medicine

New York, New York, United States

Site Status RECRUITING

Lincoln Medical and Mental Health Center

The Bronx, New York, United States

Site Status RECRUITING

Metrohealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Baylor College of Medicine

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Beilinson Hospital, Rabin Medical Center

Petah Tikva, , Israel

Site Status NOT_YET_RECRUITING

Countries

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United States Israel

Central Contacts

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Charles V. Pollack, MD

Role: CONTACT

215-829-7549

Facility Contacts

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Barbara Davis, RN, BSN

Role: primary

302-733-4189

David E Slattery, MD

Role: primary

702-383-7885 ext. 5

Janice Lam

Role: primary

212-824-8078

Muhammad Waseem, MD

Role: primary

718-579-6010

Julie Nichols, RN

Role: primary

216-957-6488

Charles Pollack

Role: primary

215-829-7549

Syed S Ali, MD

Role: primary

713-873-8555

Zvi Rotenberg, Dr

Role: primary

9723-937-7000

References

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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.

Reference Type BACKGROUND
PMID: 18773329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19085584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17551264 (View on PubMed)

Other Identifiers

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DB051

Identifier Type: -

Identifier Source: org_study_id

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