Vibration Response Imaging in Healthy Subjects

June 15, 2009 updated by: Deep Breeze

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Haifa, Israel, 310196
        • Rambam Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Mordechai Yigla, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

July 1, 2007

First Submitted That Met QC Criteria

July 1, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2009

Last Update Submitted That Met QC Criteria

June 15, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • DB013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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