Distribution of Regional Lung Function by Vibration Response Imaging
2010年10月26日 更新者：Deep Breeze
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
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
25
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ramat-Gan、以色列、52621
- Chaim Sheba Medical Center at Tel Hashomer
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Males and females who were diagnosed with moderate-to-severe COPD by lung function studies and clinical evaluation
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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COPD patients
Patients diagnosed with COPD, by the pulmonologist at the institute,who are referred to undergo ventilation/perfusion scans.
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Observational study - no intervention.
Patients underwent VRI recordings and routine V/Q scan.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
|---|---|
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Comparison of regional lung vibration energy with regional lung function
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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
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次要结果测量
结果测量 |
措施说明 |
|---|---|
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Correlation of vibration lung sound energy with regional lung functions by V/Q scan
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Evaluate if the regional vibration energy is correlated with regional lung functions, as assessed by V/Q scan
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Issahar Ben-Dov, MD、Chaim Sheba Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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. Erratum In: Eur Respir J. 2006 Jan;27(1):242.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年2月1日
初级完成 (实际的)
2006年1月1日
研究完成 (实际的)
2006年1月1日
研究注册日期
首次提交
2010年10月26日
首先提交符合 QC 标准的
2010年10月26日
首次发布 (估计)
2010年10月27日
研究记录更新
最后更新发布 (估计)
2010年10月27日
上次提交的符合 QC 标准的更新
2010年10月26日
最后验证
2010年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.