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CompletedNCT00672893Updated Jun 16, 2009

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

An observational study in Central Airway Stenosis, sponsored by Deep Breeze. Completed at 5 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2009-06-16.

Sponsored by Deep Breeze · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Central Airway Stenosis

Keywords

  • central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment
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In context

Respiratory Sounds

146 studies on the registry are indexed under Respiratory Sounds; 32 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 63 observational studies indexed under Respiratory Sounds.

Browse Respiratory Sounds studies →

Lead sponsor

Deep Breeze is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
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Study design

Time perspective
Prospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • Observation

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

    Other: Vibration Response Imaging

Interventions

  • OtherVibration Response Imaging

    12 seconds of recording lung sounds

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and follow-up up to 3 months

Secondary outcomes

  1. 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.

    Time frame: Baseline

07

Study locations

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

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. PubMed 17551264 ↗
  • 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. PubMed 15187010 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00672893
Lead sponsor
Deep Breeze
First posted
May 6, 2008
Start date
Feb 2006
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Jun 16, 2009

Study contacts

Heinrich D Becker, M.D.
principal investigator · Thoraxklinik at Heidelberg University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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