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Clinical Trials/NCT01229020
NCT01229020
Completed
Not Applicable

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

Deep Breeze1 site in 1 country25 target enrollmentFebruary 2004
ConditionsEmphysemaCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emphysema
Sponsor
Deep Breeze
Enrollment
25
Locations
1
Primary Endpoint
Comparison of regional lung vibration energy with regional lung function
Status
Completed
Last Updated
15 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
January 2006
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Deep Breeze

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Correlation of vibration lung sound energy with regional lung functions by V/Q scan

Study Sites (1)

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