Clinical trial NCT00542282: Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma
Official title: Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Keywords: lung sounds,
airway obstruction,
asthma,
auscultation
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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.

Primary outcomes:
measure: The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.
timeFrame: One day
Secondary outcomes:
measure: The secondary objective is correlating the VRI evaluations with lung function test results
timeFrame: One day
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Kalpalatha K Guntupalli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1183/09031936.03.00040403.
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: 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. doi: 10.1186/cc5706.