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Distribution of Regional Lung Function by Vibration Response Imaging

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT01229020
First received: October 26, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 26, 2010
October 26, 2010
February 2004
January 2006   (final data collection date for primary outcome measure)
Comparison of regional lung vibration energy with regional lung function [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
Correlation of vibration lung sound energy with regional lung functions by V/Q scan [ Designated as safety issue: No ]
Evaluate if the regional vibration energy is correlated with regional lung functions, as assessed by V/Q scan
Same as current
Not Provided
Not Provided
 
Distribution of Regional Lung Function by Vibration Response Imaging
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Males and females who were diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
January 2006
January 2006   (final data collection date for primary outcome measure)

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

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01229020
DB010
No
Merav Gat / VP of Clinical and Regulatory Affairs, Deep Breeze
Deep Breeze
Not Provided
Principal Investigator: Issahar Ben-Dov, MD Chaim Sheba Medical Center
Deep Breeze
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP