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Vibration Response Imaging in Healthy Subjects

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Deep Breeze.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00495430
First received: July 1, 2007
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  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 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
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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: July 2009
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
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.

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

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

Publications:

Responsible Party: Merav Gat/VP Clinical Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT00495430     History of Changes
Other Study ID Numbers: DB013
Study First Received: July 1, 2007
Last Updated: June 15, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Deep Breeze:
Healthy
Lung sounds
Breath sounds

ClinicalTrials.gov processed this record on May 19, 2013