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OpenTrials
Completed

NCT Number: NCT00672893

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital St. Marguerite, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Vibration Response Imaging

Other

12 seconds of recording lung sounds

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

Sponsors and collaborators

Lead sponsor

Deep Breeze

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 6, 2008
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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