Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

NCT ID: NCT00672893

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-12-31

Brief Summary

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Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

Detailed Description

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Conditions

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Central Airway Stenosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Observation

Patients who present to the clinic with airway obstruction and who are designated to undergo intervention

Vibration Response Imaging

Intervention Type OTHER

12 seconds of recording lung sounds

Interventions

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Vibration Response Imaging

12 seconds of recording lung sounds

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent.
* Male or female in the age range of 18-85 years.
* Body Mass Index \>20.
* Patient presented with airway obstruction and who are designated to undergo intervention

Exclusion Criteria

* Chest wall deformity;
* Spine deformity (including severe scoliosis or kyphosis);
* Hirsutism;
* Potentially contagious skin lesion on the back;
* Skin lesion that would interfere with sensor placement;
* Patient is pregnant;
* Cardiac pacemaker or implantable defibrillator;
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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Thoraxklinik at Heidelberg University

Principal Investigators

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Heinrich D Becker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik at Heidelberg University School of Medicine

Locations

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National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Hospital St. Marguerite

Marseille, , France

Site Status

Thoraxklinik at Heidelberg University

Heidelberg, , Germany

Site Status

St. Marianna Hospital

Kawasaki, Kanagawa, Japan

Site Status

Countries

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United States France Germany Japan

References

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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)

Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. doi: 10.1164/rccm.200210-1181SO.

Reference Type BACKGROUND
PMID: 15187010 (View on PubMed)

Other Identifiers

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DB020-Single-site

Identifier Type: -

Identifier Source: secondary_id

DB035-Multi-site

Identifier Type: -

Identifier Source: org_study_id

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