Distribution of Regional Lung Function by Vibration Response Imaging

NCT01229020 | Completed

• 1 other identifier: DB010
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Emphysema; COPD

Keywords

Emphysema; COPD; lung sounds; vibration response imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of vibration lung sound energy with regional lung functions by V/Q scan

Study Arms (1)

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

Interventions

Observational study - no intervention OTHER

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

COPD patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Deep Breeze: lead

Study Sites (1)

Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, 52621, Israel

Location

Related 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. doi: 10.1183/09031936.04.00014304. No abstract available.

  PMID: 15219010 BACKGROUND

• 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.

  PMID: 16456733 BACKGROUND

• 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.

  PMID: 18022081 BACKGROUND

• 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.

  PMID: 8635364 BACKGROUND

• 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.

  PMID: 19085584 BACKGROUND

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive; Respiratory Sounds

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Issahar Ben-Dov, MD

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: February 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: October 27, 2010

Record last verified: 2010-10

Locations

IL (1)