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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473291
• Other study ID #: DB029
• Status: Completed
• Phase: N/A
• First received: May 14, 2007
• Last updated: June 15, 2009
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2009
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pleural Effusion

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center, Harvard Medical School	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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

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. — View Citation