Vibration Response Imaging in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495430
Recruitment Status : Unknown
Verified June 2009 by Deep Breeze.
Recruitment status was:  Active, not recruiting
First Posted : July 3, 2007
Last Update Posted : June 16, 2009
Information provided by:
Deep Breeze

Brief 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.

Condition or disease

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.

Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects
Study Start Date : December 2004
Estimated Study Completion Date : July 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects who presented for complete physical examination as required by place of employment. Convenience sample - consecutive healthy subjects who meet study criteria are included in the study.

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00495430

Rambam Medical Center
Haifa, Israel, 310196
Sponsors and Collaborators
Deep Breeze
Principal Investigator: Mordechai Yigla, MD Rambam Health Care Campus

Responsible Party: Merav Gat/VP Clinical Affairs, Deep Breeze Identifier: NCT00495430     History of Changes
Other Study ID Numbers: DB013
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Deep Breeze:
Lung sounds
Breath sounds