Vibration Response Imaging in Healthy Subjects

Healthy Clinical Trial

Official title:

Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00495430
• Other study ID #: DB013
• Status: Active, not recruiting
• Phase: N/A
• First received: July 1, 2007
• Last updated: June 15, 2009
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: June 2009
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The primary purpose is to test intersubject variability and establish the qualitative features of normal VRI images and the range of normality of the VRI quantitative lung data values that may be used to differentiate normal from abnormal breath sound distribution. Our hypothesis was that VRI breath sound images of healthy subjects are similar in a qualitative and quantitative manner.

Description:

Computerized analyses have shown that normal lung sounds have distinctive characteristic that can be differentiated from abnormal lung sounds.However, technical issues and complicated display modes have restricted the use of computerized lung sound analyses in the clinical environment.

The VRI provides dynamic gray-scale images and quantitative lung data showing the breath sound distribution of healthy individuals. Typical features that are discerned by trained raters and quantitative lung data may serve as a reference for comparison to abnormal breath sound images.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Able and willing to read, understands, and provides written Informed Consent;

• Male or Female in the age range of 18-85 years;

• Subject is healthy and has not exhibited symptoms of acute respiratory tract disease for the past two months;

• Subject has normal chest X-ray and normal lung function during the past 6 months that were judged stable;

• BMI > 21.

Exclusion Criteria:

• Subject has a history of a chronic condition that affects the lungs or heart (e.g.chronic obstructive pulmonary disease, asthma, congestive heart failure) or is suspected of having such a condition;

• Subject has a chest cage deformation;

• Subject has spine deformation (including severe scoliosis);

• Subject is Hirsute;

• Subject has a skin lesion (potentially contagious) on the back;

• Subject has a cardiac pacemaker or implantable defibrillator;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. Epub 2007 Jun 4. — View Citation

Ploysongsang Y, Iyer VK, Ramamoorthy PA. Reproducibility of the vesicular breath sounds in normal subjects. Respiration. 1991;58(3-4):158-62. — View Citation