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OpenTrials
Completed

NCT Number: NCT01229020

Distribution of Regional Lung Function by Vibration Response Imaging

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, 52621, Israel

About this study

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.

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 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; 9. Cardiac pacemaker or implantable defibrillator

Treatment and study plan

Observational study - no intervention

Other

Observational study - no intervention. Patients underwent VRI recordings and routine V/Q scan.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Deep Breeze

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 27, 2010
Registry last updated
Oct 27, 2010

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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