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

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00473291
First received: May 14, 2007
Last updated: June 15, 2009
Last verified: June 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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