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

NCT00473291 | Completed

• 1 other identifier: DB029
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Keywords

pleural effusion; lung sounds; acoustic monitoring

Study Arms (1)

Patients with pleural effusion

Patients diagnosed with pleural effusion and presenting for treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with pleural effusion

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (1)

Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

• 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.

  PMID: 7781353 BACKGROUND

• 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.

  PMID: 9106577 BACKGROUND

• 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.

  PMID: 10210486 BACKGROUND

• 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.

  PMID: 17316449 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Respiratory Sounds

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Armin Ernst, M.D.

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: November 1, 2006
• Study Completion: December 1, 2007
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

US (1)