Vibration Response Imaging in Healthy Subjects

NCT ID: NCT00495430

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Deep Breeze

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deep Breeze

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mordechai Yigla, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rambam Medical Center

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17551264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1745848 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DB013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.