Vibration Response Imaging in Healthy Subjects - Full Text View

Sponsored by:	Deep Breeze
Information provided by:	Deep Breeze
ClinicalTrials.gov Identifier:	NCT00495430

Purpose

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 quantitave 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.

Condition
Healthy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects

Further study details as provided by Deep Breeze:

Estimated Enrollment:	310
Study Start Date:	December 2004
Estimated Study Completion Date:	June 2008

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495430

Contacts

Contact: Iris Marom

+972 4 8542650

i_marom@rambam.health.gov.il

Locations

Israel
Rambam Medical Center	Recruiting
Haifa, Israel, 310196

Sponsors and Collaborators

Deep Breeze

Investigators

Principal Investigator:

Mordechai Yigla, MD

Rambam Health Care Campus

More Information

Publications:

Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic Visualization of Lung Sounds with a Vibration Response Device: A Case Series. Respiration. 2007 Jun 4; [Epub ahead of print]

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

Study ID Numbers:	DB013
Study First Received:	July 1, 2007
Last Updated:	July 1, 2007
ClinicalTrials.gov Identifier:	NCT00495430 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Deep Breeze:

Healthy
Lung sounds
Breath sounds

Study placed in the following topic categories:

Respiratory Sounds
Healthy

ClinicalTrials.gov processed this record on May 06, 2009