Distribution of Regional Lung Function by Vibration Response Imaging

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229020
• Other study ID #: DB010
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: October 26, 2010
• Start date: February 2004
• Est. completion date: January 2006

Study information

• Verified date: October 2010
• Source: Deep Breeze
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Emphysema

Intervention

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

Locations

Country	Name	City	State
Israel	Chaim Sheba Medical Center at Tel Hashomer	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Deep Breeze

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. Erratum in: Eur Respir J. 2006 Jan;27(1):242. — View Citation

Demir T, Ikitimur H, Akpinar Tekgündüz 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. — View 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. — View Citation

Ikonen T, Harjula AL, Kinnula V, Savola J, Sovijärvi AR. Selective assessment of single-lung graft function with 133Xe radiospirometry in acute rejection and infection. Chest. 1996 Apr;109(4):879-84. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	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		No