Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion - Full Text View

Purpose

The primary purpose of this study is evaluate the VRI device's accuracy in diagnosis of pleural effusion (in comparison to chest x-ray and ultrasonography), and to assess the pleural effusion location and size. The VRI system uses pressure sensors (electronic stethoscopes) to record the energy created by the airflow in the lungs during breathing.

Condition
Pleural Effusion

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion

Further study details as provided by Deep Breeze:

Estimated Enrollment:	80
Study Start Date:	November 2006
Study Completion Date:	December 2007

Groups/Cohorts
Patients with pleural effusion Patients diagnosed with pleural effusion and presenting for treatment

Detailed Description:

The accumulation of excess fluid in the pleural cavity of the lungs, known as pleural effusion, is a common clinical condition that may be the result of trauma or disease. Diagnosis and management of pleural effusion can be done by X-Ray or ultrasound; however X-Ray emits radiation, requires a special room and expert personnel, while ultrasound requires a high level of expertise to perform and analyze. The VRI device is non-invasive and radiation free. The VRI device is a simple method to image the lungs in a regional manner to examine changes that occur during pleural effusion.

Comparison: X-ray and ultrasonography evaluations of pleural effusion, compared to VRI acoustic imaging evaluations.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with pleural effusion

Criteria

Inclusion Criteria:

Able and willing to read, understand, and provide written Informed Consent;
Male or Female in the age range of 18-85 years;
Subject is suspected to have pleural effusion;
Body mass index (BMI) > 21.

Exclusion Criteria:

Chest wall deformation;
Spine deformation (including severe scoliosis);
Hirsutism;
Potentially contagious skin lesion on the back;
Skin lesion that would interfere with sensor placement;
Cardiac pacemaker or implantable defibrillator;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473291

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Deep Breeze

Investigators

Principal Investigator:

Armin Ernst, M.D.

Beth Israel Deaconess Medical Center

More Information

Publications:

Marel M, Stastny B, Melinova L, Svandova E, Light RW. Diagnosis of pleural effusions. Experience with clinical studies, 1986 to 1990. Chest. 1995 Jun;107(6):1598-603.

Heffner JE, Brown LK, Barbieri CA. Diagnostic value of tests that discriminate between exudative and transudative pleural effusions. Primary Study Investigators. Chest. 1997 Apr;111(4):970-80.

Mergo PJ, Helmberger T, Didovic J, Cernigliaro J, Ros PR, Staab EV. New formula for quantification of pleural effusions from computed tomography. J Thorac Imaging. 1999 Apr;14(2):122-5.

Dellinger RP, Jean S, Cinel I, Tay C, Rajanala S, Glickman YA, Parrillo JE. Regional distribution of acoustic-based lung vibration as a function of mechanical ventilation mode. Crit Care. 2007;11(1):R26.

Responsible Party:	Merav Gat/VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier:	NCT00473291 History of Changes
Other Study ID Numbers:	DB029
Study First Received:	May 14, 2007
Last Updated:	June 15, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Deep Breeze:

pleural effusion
lung sounds
acoustic monitoring

Additional relevant MeSH terms:

Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013