Asthma Clinical Trial
Official title:
Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators
Verified date | June 2009 |
Source | Deep Breeze |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Deep Breeze |
United States,
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. — View 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. Epub 2007 Jun 4. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators. | One day | No | |
Secondary | The secondary objective is correlating the VRI evaluations with lung function test results | One day | No |
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