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

Central Airway Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672893
• Other study ID #: DB035-Multi-site
• Secondary ID: DB020-Single-sit
• Status: Completed
• Phase: N/A
• First received: May 1, 2008
• Last updated: June 15, 2009
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Airway Stenosis

Intervention

Other:
• Vibration Response Imaging
12 seconds of recording lung sounds

Locations

Country	Name	City	State
France	Hospital St. Marguerite	Marseille
Germany	Thoraxklinik at Heidelberg University	Heidelberg
Japan	St. Marianna Hospital	Kawasaki	Kanagawa
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Countries where clinical trial is conducted

United States,  France,  Germany,  Japan, 

References & Publications (2)

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. Epub 2007 Jun 4. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline and follow-up up to 3 months	No
Secondary	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.		Baseline	No