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.

Study Overview

• Status: Completed
• Conditions: Emphysema; COPD
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel, 52621
    • Chaim Sheba Medical Center at Tel Hashomer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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

Collaborators and Investigators

• Sponsor: Deep Breeze
• Investigators: Principal Investigator: Issahar Ben-Dov, MD, Chaim Sheba Medical Center

Publications and helpful links

General Publications

• Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available. Erratum In: Eur Respir J. 2006 Jan;27(1):242.
• Demir T, Ikitimur H, Akpinar Tekgunduz S, Mutlu B, Yildirim N, Akman C, Ozmen O, Kanmaz B. The relationship between pulmonary function tests, thorax HRCT, and quantitative ventilation-perfusion scintigraphy in chronic obstructive pulmonary disease. Tuberk Toraks. 2005;53(4):347-53.
• Kramer MR, Raviv Y, Hardoff R, Shteinmatz A, Amital A, Shitrit D. Regional breath sound distribution analysis in single-lung transplant recipients. J Heart Lung Transplant. 2007 Nov;26(11):1149-54. doi: 10.1016/j.healun.2007.07.039.
• Ikonen T, Harjula AL, Kinnula V, Savola J, Sovijarvi AR. Selective assessment of single-lung graft function with 133Xe radiospirometry in acute rejection and infection. Chest. 1996 Apr;109(4):879-84. doi: 10.1378/chest.109.4.879.
• Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): January 1, 2006
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): October 27, 2010
• Last Update Submitted That Met QC Criteria: October 26, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: COPD; Emphysema; lung sounds; vibration response imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: DB010