Distribution of Regional Lung Function by Vibration Response Imaging

Sponsor

Deep Breeze (Industry)

Overall Status

Completed

CT.gov ID

NCT01229020

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

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 :

Feb 1, 2004

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.