Clinical trial NCT01229020: Distribution of Regional Lung Function by Vibration Response Imaging
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emphysema
COPD
Keywords: Emphysema
COPD
lung sounds
vibration response imaging
Lead sponsor: Deep Breeze
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females who were diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation

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.

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.

  8. Previous resection lung surgery and history of lung tumor; 9. Cardiac pacemaker or implantable defibrillator

Primary outcomes:
measure: Comparison of regional lung vibration energy with regional lung function
Secondary outcomes:
measure: Correlation of vibration lung sound energy with regional lung functions by V/Q scan
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center at Tel Hashomer
Study officials:
affiliation: Chaim Sheba Medical Center
name: Issahar Ben-Dov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.