Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure
- Conditions
- Central Airway Stenosis
- Interventions
- Other: Vibration Response Imaging
- Registration Number
- NCT00672893
- Lead Sponsor
- Deep Breeze
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation Vibration Response Imaging Patients who present to the clinic with airway obstruction and who are designated to undergo intervention
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (5)
St. Marianna Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Hospital St. Marguerite
🇫🇷Marseille, France
National Jewish Medical and Research Center
🇺🇸Denver, Colorado, United States
Thoraxklinik at Heidelberg University
🇩🇪Heidelberg, Germany
Duke University Medical Center
🇺🇸Durham, North Carolina, United States