Distribution of Regional Lung Function by Vibration Response Imaging

This study has been completed.
Sponsor:
Information provided by:
Deep Breeze
ClinicalTrials.gov Identifier:
NCT01229020
First received: October 26, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Emphysema
COPD
Other: Observational study - no intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Deep Breeze:

Primary Outcome Measures:
  • Comparison of regional lung vibration energy with regional lung function [ Designated as safety issue: No ]
    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:
  • Correlation of vibration lung sound energy with regional lung functions by V/Q scan [ Designated as safety issue: No ]
    Evaluate if the regional vibration energy is correlated with regional lung functions, as assessed by V/Q scan


Enrollment: 25
Study Start Date: February 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01229020

Locations
Israel
Chaim Sheba Medical Center at Tel Hashomer
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Deep Breeze
Investigators
Principal Investigator: Issahar Ben-Dov, MD Chaim Sheba Medical Center
  More Information

Publications:
Responsible Party: Merav Gat / VP of Clinical and Regulatory Affairs, Deep Breeze
ClinicalTrials.gov Identifier: NCT01229020     History of Changes
Other Study ID Numbers: DB010
Study First Received: October 26, 2010
Last Updated: October 26, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Deep Breeze:
Emphysema
COPD
lung sounds
vibration response imaging

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Pathologic Processes
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014