Clinical trial NCT00672893: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Official title: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Airway Stenosis
Keywords: central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the age range of 18-85 and consisting of both male and females, who present to the clinic with airway obstruction and who are designated to undergo intervention.

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: The principal objective is to determine the ability of the VRI to assess changes in the lungs before and after pulmonary intervention in patients suffering from airway obstruction.
timeFrame: Baseline and follow-up up to 3 months
Secondary outcomes:
measure: The secondary objective is to assess the contribution of the VRI in aiding in identification of the pulmonary obstruction as compared to the standard methods prior the intervention procedure.
timeFrame: Baseline
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Marseille
country: France
facility: Hospital St. Marguerite
city: Heidelberg
country: Germany
facility: Thoraxklinik at Heidelberg University
city: Kawasaki
country: Japan
facility: St. Marianna Hospital
state: Kanagawa
Study officials:
affiliation: Thoraxklinik at Heidelberg University School of Medicine
name: Heinrich D Becker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.