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OpenTrials
Completed

NCT Number: NCT00542282

Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The primary study objective is evaluation of the VRI qualitative and quantitative assessment before and after spirometry with bronchodilators.

    Time frame: One day

Secondary outcomes

  1. The secondary objective is correlating the VRI evaluations with lung function test results

    Time frame: One day

Sponsors and collaborators

Lead sponsor

Deep Breeze

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Oct 11, 2007
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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