Distribution of Regional Lung Function by Vibration Response Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01229020
Recruitment Status : Completed
First Posted : October 27, 2010
Last Update Posted : October 27, 2010
Information provided by:
Deep Breeze

Brief Summary:
Assessment of regional contribution of different areas of the lung to its integrated function is often required, such as prior to lung resection in the presence of tumor or emphysema. This assessment is derived from the proportion of zonal radionuclear perfusion or ventilation. The investigators hypothesized that lung VRI may provide an alternative approach to assess regional lung function.

Condition or disease Intervention/treatment
Emphysema COPD Other: Observational study - no intervention

Detailed Description:
Patients diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation presented in stable clinical condition and were evaluated by lung sound recordings and quantitative V/Q lung scintigraphy. Regional signals (percentage of lung sounds) for left and right lungs were compared with the corresponding regional count percentages of each radionuclide scan, by V/Q scan regions of interest.

Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Distribution of Regional Lung Function, as Determined by the Vibration Response Image Generated by the VRI-2000 System as Compared With Standard Radio-nuclear Method
Study Start Date : February 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Group/Cohort Intervention/treatment
COPD patients
Patients diagnosed with COPD, by the pulmonologist at the institute,who are referred to undergo ventilation/perfusion scans.
Other: Observational study - no intervention
Observational study - no intervention. Patients underwent VRI recordings and routine V/Q scan.

Primary Outcome Measures :
  1. Comparison of regional lung vibration energy with regional lung function
    To map regional lung vibration energy in patients with emphysema by using the lung image generated by the VRI system and compare findings to distibution of perfusion and ventilation in standard V/Q scans

Secondary Outcome Measures :
  1. Correlation of vibration lung sound energy with regional lung functions by V/Q scan
    Evaluate if the regional vibration energy is correlated with regional lung functions, as assessed by V/Q scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Males and females who were diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation

Inclusion Criteria:

  • Patient is able to read and understand the Informed Consent Form and he/she will provide written Informed Consent.
  • Male or female in the age range of 18-85 years.
  • The patient will undergo V/Q scan (up to ONE WEEK from the VRI recording)
  • The patient presented for evaluation of COPD.
  • Body Mass Index >21.

Exclusion Criteria:

  • Unstable clinical status such as fever, acute shortness of breath, cough, hemoptysis, cheat pain, or acute chest illness.
  • Chest wall deformation;
  • Spine deformation (including severe scoliosis);
  • Hirsutism;
  • Potentially contagious skin lesion on the back;
  • Skin lesion that would interfere with sensor placement;
  • Any additional chronic lung disease of any findings such as past tuberculosis, visualized on CXR.

    8. Previous resection lung surgery and history of lung tumor; 9. Cardiac pacemaker or implantable defibrillator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01229020

Chaim Sheba Medical Center at Tel Hashomer
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Deep Breeze
Principal Investigator: Issahar Ben-Dov, MD Chaim Sheba Medical Center

Responsible Party: Merav Gat / VP of Clinical and Regulatory Affairs, Deep Breeze Identifier: NCT01229020     History of Changes
Other Study ID Numbers: DB010
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2010

Keywords provided by Deep Breeze:
lung sounds
vibration response imaging

Additional relevant MeSH terms:
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases