Electrical Impedance Tomography (EIT): A Non-radiating Functional Imaging for Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Sensitivity and specificity for identifying air trapping and consolidation
研究概览
简要总结
The goal of this feasibility study is to evaluate the ability of Electrical Impedance Tomography (EIT) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. It is not being conducted to diagnose, treat, prevent, or cure any kind of disease. In electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. The computed properties are used to form an image, which can then be used for monitoring and diagnosis.
详细描述
The goal of this study is to evaluate the ability of Electrical Impedance Tomography (EIT) hardware and software in patients with cystic fibrosis (CF) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (PE). In particular, EIT will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in CF patients, and to determine whether EIT can demonstrate the beneficial effects of antibiotic treatment for CF patients with an acute PE by correlating changes in quantitative EIT measures with clinical measures known to improve following therapy, with patients serving as their own controls. Regional changes in air trapping and consolidation from pre to post treatment as indicated by the EIT images will be calculated, with subjects serving as their own control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 2 and 21 years (Groups 1 and 2)
- •Between the ages of 8 and 21 years (Group 3)
- •Healthy lungs (Group 1)
- •Clinical diagnosis of cystic fibrosis (Groups 2 and 3)
- •Clinically indicated for a pulmonary CT scan or will receive one as part of their routine care (Group 2)
- •Receiving IV antibiotics for a clinically diagnosed pulmonary exacerbation (Group 3)
排除标准
- •Under age 24 months or over age
- •No informed consent
- •Known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant.
- •Pregnant or lactating
结局指标
主要结局
Sensitivity and specificity for identifying air trapping and consolidation
时间窗: 2 years
The sensitivity and specificity of EIT for identifying regions of air trapping and consolidation will be assessed using the CT scan as the gold standard
次要结局
- Accuracy of the EIT computed spirometry values(2 years)
- Correlation of EIT derived measures to patient improvement following IV antibiotics(2 years)