Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

June 15, 2009 updated by: Deep Breeze

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deep Breeze

Investigators

Principal Investigator: Kalpalatha K Guntupalli, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria