Vibration Response Imaging in Chronic Obstructive Pulmonary Disease and Asthma

NCT ID: NCT00542282

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1, 2, 3

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deep Breeze

INDUSTRY

Sponsor Role lead

Responsible Party

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Deep Breeze

Principal Investigators

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Kalpalatha K Guntupalli, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12572697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17551264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17316449 (View on PubMed)

Other Identifiers

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DB033

Identifier Type: -

Identifier Source: org_study_id

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