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

NCT ID: NCT00473291

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Pleural Effusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with pleural effusion

Patients diagnosed with pleural effusion and presenting for treatment

No interventions assigned to this group

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Breeze

INDUSTRY

Sponsor Role lead

Responsible Party

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Deep Breeze

Principal Investigators

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Armin Ernst, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center, Harvard Medical School

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 7781353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9106577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10210486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17316449 (View on PubMed)

Other Identifiers

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DB029

Identifier Type: -

Identifier Source: org_study_id

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