Clinical trial NCT00473291: Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion
Official title: Vibration Response Imaging (VRI) in Management and Evaluation in Patients With Pleural Effusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Keywords: pleural effusion
lung sounds
acoustic monitoring
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2007-05-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pleural effusion

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.

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 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;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center, Harvard Medical School
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Armin Ernst, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1378/chest.107.6.1598.
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. doi: 10.1378/chest.111.4.970.
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. doi: 10.1097/00005382-199904000-00011.
citation: 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. doi: 10.1186/cc5706.