Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

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: NCT00542282
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : June 16, 2009
Information provided by:
Deep Breeze

Brief Summary:

Obstructive lung disease is usually a differential diagnostic consideration when a patient presents with breathlessness or cough. Spirometry is the key diagnostic test used to confirm airflow obstruction particularly in the primary care setting. Airflow obstruction that completely resolves after administration of a bronchodilator, by definition, excludes a diagnosis of COPD. Evaluation of obstructive lung disease must include pulmonary function testing; bronchoreversibility testing is an adjunct in differentiating between asthma and COPD. Bronchoreversibility cannot serve as an absolute diagnostic criterion for separating asthma from COPD.

Vibration response imaging (VRI) technology provides a simple, radiation-free method to image the lungs, by visualizing vibration energy (lung sounds) emitted during respiration cycle. In this study, regional quantitative and qualitative information on vibration response is compared with spirometry in assessing lungs function of COPD and Asthma patients.

Condition or disease
Chronic Obstructive Pulmonary Disease Asthma

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators
Study Start Date : November 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

1, 2, 3
known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease

Primary Outcome Measures :
  1. The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. [ Time Frame: One day ]

Secondary Outcome Measures :
  1. The secondary objective is correlating the VRI evaluations with lung function test results [ Time Frame: One day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are either suspected of pulmonary obstruction or already diagnosed and are scheduled to perform a spirometry test with pre and post administration of bronchodilators will be enrolled in this study

Inclusion Criteria:

  • Able and willing to read, understand, and provide written Informed Consent
  • Male or Female in the age range of 18-85 years
  • Patients referred for evaluation of known or suspected obstructive airways disease.
  • Subject is referred for pulmonary function testing with pre-and post- bronchodilator
  • BMI > 21
  • Patients who are treated with Bronchodilators should go through a washout period prior the VRI procedure according to the Pulmonary Function Laboratory protocol.
  • Stable clinical condition at study baseline evaluation.

Exclusion Criteria:

  • Chest wall deformation
  • Spine deformation (including severe scoliosis)
  • Hirsutism
  • Potentially contagious skin lesion on the back
  • Skin lesion that would interfere with sensor placement
  • Pregnant or lactating females.

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): NCT00542282

United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Deep Breeze
Principal Investigator: Kalpalatha K Guntupalli, MD Baylor College of Medicine

Responsible Party: Merav Gat/VP Clinical Affairs, Deep Breeze Identifier: NCT00542282     History of Changes
Other Study ID Numbers: DB033
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Deep Breeze:
lung sounds,
airway obstruction,

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases