Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma - Full Text View

Sponsored by:	Deep Breeze
Information provided by:	Deep Breeze
ClinicalTrials.gov Identifier:	NCT00542282

Purpose

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
Chronic Obstructive Pulmonary Disease Asthma

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators

Further study details as provided by Deep Breeze:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	75
Study Start Date:	November 2006

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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542282

Contacts

Contact: Caryn O Pope

713-873-2471

cpope@bcm.tmc.edu

Locations

United States, Texas
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Kalpalatha K Guntupalli, MD

Sponsors and Collaborators

Deep Breeze

Investigators

Principal Investigator:

Kalpalatha K Guntupalli, MD

Baylor College of Medicine

More Information

Publications:

van Schayck CP, Chavannes NH. Detection of asthma and chronic obstructive pulmonary disease in primary care. Eur Respir J Suppl. 2003 Jan;39:16s-22s. Review.

Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic Visualization of Lung Sounds with a Vibration Response Device: A Case Series. Respiration. 2007 Jun 4; [Epub ahead of print]

Dellinger RP, Jean S, Cinel I, Tay C, Rajanala S, Glickman YA, Parrillo JE. Regional distribution of acoustic-based lung vibration as a function of mechanical ventilation mode. Crit Care. 2007;11(1):R26.

Study ID Numbers:	DB033
Study First Received:	October 10, 2007
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00542282
Health Authority:	United States: Institutional Review Board

Keywords provided by Deep Breeze:

lung sounds,
airway obstruction,
asthma,
auscultation

Study placed in the following topic categories:

Hypersensitivity
Respiratory Sounds
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Hypersensitivity, Immediate
Asthma
Airway Obstruction
Respiratory Hypersensitivity
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 15, 2009