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

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT00672893
First received: May 1, 2008
Last updated: June 15, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Central Airway Stenosis
 Other: Vibration Response Imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

Resource links provided by NLM:

MedlinePlus related topics: Choking
U.S. FDA Resources

Further study details as provided by Deep Breeze:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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.

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672893

Locations
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80602
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
France
Hospital St. Marguerite
Marseille, France, 13274
Germany
Thoraxklinik at Heidelberg University
Heidelberg, Germany, D-69126
Japan
St. Marianna Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Heinrich D Becker, M.D. Thoraxklinik at Heidelberg University School of Medicine
  More Information

Publications:

Responsible Party: Prof. Heinrich D. Becker, MD, Thoraxklinik at Heidelberg University
ClinicalTrials.gov Identifier: NCT00672893     History of Changes
Other Study ID Numbers: DB035-Multi-site, DB020-Single-site
Study First Received: May 1, 2008
Last Updated: June 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Deep Breeze:
central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013