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Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion

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ClinicalTrials.gov Identifier: NCT00473291
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : June 16, 2009
Information provided by:
Deep Breeze

Brief Summary:
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 or disease
Pleural Effusion

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.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion
Study Start Date : November 2006
Study Completion Date : December 2007

Patients with pleural effusion
Patients diagnosed with pleural effusion and presenting for treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with pleural effusion

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00473291

United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Deep Breeze
Principal Investigator: Armin Ernst, M.D. Beth Israel Deaconess Medical Center