Clinical trial NCT00495430: Vibration Response Imaging in Healthy Subjects
Official title: Passive Acoustic Imaging With the Vibration Response Imaging Device in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Healthy
Lung sounds
Breath sounds
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Mordechai Yigla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1159/000103558. Epub 2007 Jun 4.
citation: Ploysongsang Y, Iyer VK, Ramamoorthy PA. Reproducibility of the vesicular breath sounds in normal subjects. Respiration. 1991;58(3-4):158-62. doi: 10.1159/000195918.