Distribution of Regional Lung Function by Vibration Response Imaging

NCT ID: NCT01229020

Last Updated: 2010-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-01-31

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.

Conditions

Emphysema; COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients

Patients diagnosed with COPD, by the pulmonologist at the institute,who are referred to undergo ventilation/perfusion scans.

Observational study - no intervention

Intervention Type: OTHER

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

Interventions

Observational study - no intervention

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deep Breeze

INDUSTRY

Sponsor Role: lead

Responsible Party

Deep Breeze

Principal Investigators

Issahar Ben-Dov, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 15219010 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16456733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18022081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8635364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19085584 (View on PubMed)

Other Identifiers

DB010

Identifier Type: -

Identifier Source: org_study_id