NCT00672893

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

May 1, 2008

Last Update Submit

June 15, 2009

Conditions

Central Airway Stenosis

Keywords

central airway stenosis, lung sounds, airway obstruction, bronchial obstruction, bronchoscopic treatment

Outcome Measures

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.

    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.

    Baseline

Study Arms (1)

Observation

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

Other: Vibration Response Imaging

Interventions

Vibration Response ImagingOTHER

12 seconds of recording lung sounds

Observation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

National Jewish Medical and Research Center

Denver, Colorado, 80602, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hospital St. Marguerite

Marseille, 13274, France

Location

Thoraxklinik at Heidelberg University

Heidelberg, D-69126, Germany

Location

St. Marianna Hospital

Kawasaki, Kanagawa, 216-8511, Japan

Location

Related 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. doi: 10.1159/000103558. Epub 2007 Jun 4.

    PMID: 17551264BACKGROUND

  • 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.

    PMID: 15187010BACKGROUND

MeSH Terms

Conditions

Respiratory SoundsAirway Obstruction

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Heinrich D Becker, M.D.

    Thoraxklinik at Heidelberg University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 6, 2008

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 16, 2009

Record last verified: 2009-06

Locations

JP(1)FR(1)US(2)DE(1)