Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

NCT00542282 | Completed

• 1 other identifier: DB033
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma

Keywords

lung sounds,; airway obstruction,; asthma,; auscultation

Outcome Measures

Primary Outcomes (1)

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

  One day

Secondary Outcomes (1)

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

  One day

Study Arms (1)

1, 2, 3

known moderate to severe COPD, known moderate or severe Asthma, suspected obstructive moderate to severe airways disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (3)

• 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.

  PMID: 12572697 BACKGROUND

• 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.

  PMID: 17551264 BACKGROUND

• 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.

  PMID: 17316449 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Respiratory Sounds; Airway Obstruction

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders

Study Officials

• Kalpalatha K Guntupalli, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: November 1, 2006
• Study Completion: August 1, 2007
• Last Updated: June 16, 2009

Record last verified: 2009-06

Locations

US (1)