跳至主要内容
临床试验/NCT01229020
NCT01229020已完成不适用

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

Deep Breeze1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Comparison of regional lung vibration energy with regional lung function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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;
  • Cardiac pacemaker or implantable defibrillator

结局指标

主要结局

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

次要结局

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

研究者

发起方
Deep Breeze
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验