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

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.

Study Overview

• Status: Completed
• Conditions: Central Airway Stenosis
• Intervention / Treatment: Other: Vibration Response Imaging

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13274
    • Hospital St. Marguerite
• Germany
  • Heidelberg, Germany, D-69126
    • Thoraxklinik at Heidelberg University
• Japan
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna Hospital
• United States
  • Colorado
    • Denver, Colorado, United States, 80602
      • National Jewish Medical and Research Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; Patients who present to the clinic with airway obstruction and who are designated to undergo intervention	Other: Vibration Response Imaging; 12 seconds of recording lung sounds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Deep Breeze
• Investigators: Principal Investigator: Heinrich D Becker, M.D., Thoraxklinik at Heidelberg University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): June 16, 2009
• Last Update Submitted That Met QC Criteria: June 15, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: DB035-Multi-site; DB020-Single-site