Distribution of Regional Lung Function by Vibration Response Imaging

Completed

• Conditions: Emphysema; COPD
• Interventions: Other: Observational study - no intervention

• Registration Number: NCT01229020
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-02
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2010-10
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Last Update Submitted: 2010-10-26
• Study First Posted: 2010-10-27
• Last Update Posted: 2010-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients	Observational study - no intervention	Patients diagnosed with COPD, by the pulmonologist at the institute,who are referred to undergo ventilation/perfusion scans.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Chaim Sheba Medical Center at Tel Hashomer; 🇮🇱 Ramat-Gan, Israel