Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

Asthma Clinical Trial

Official title:

Evaluation of Vibration Response Imaging (VRI) in Chronic Obstructive Pulmonary Disease and Asthma Patients Before and After Bronchodilators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542282
• Other study ID #: DB033
• Status: Completed
• Phase: N/A
• First received: October 10, 2007
• Last updated: June 15, 2009
• Start date: November 2006
• Est. completion date: August 2007

Study information

• Verified date: June 2009
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2007
• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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