Real-Time Assessment of Lung Structure and Function in Children and Young Adults With CF Using Electrical Impedance Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Identification of air trapping and consolidation by EIT
研究概览
简要总结
The purpose of this study is to determine the ability of electrical impedance tomography (EIT) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. The investigators also aim to determine whether EIT can serve as an alternative for CT to identify regions of air trapping and consolidation, whether EIT can provide clinically useful information about response to treatment for an acute PE, and whether EIT can provide longitudinal information about structural changes in the lung.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3-21 years
- •Male or female
- •Healthy subjects with no known or suspected chronic or temporary lung disease
- •Age 3-21 years
- •Male or female
- •CF as diagnosed based on sweat chloride value(>60 mmol/L) or two known disease causing mutations
- •Age 3-21 years
- •Male or female
- •CF as diagnosed based on sweat chloride value (>60 mmol/L) or two known disease causing mutations
- •Experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics
排除标准
- •Unwilling/refusal to sign consent
- •Known congenital heart disease, arrhythmia, or history of heart failure
- •Wearing a pacemaker or a metallic surgical implant in the chest
- •History of infection with Burkholderia cepacia
- •Developmental delays that could result in an inability to complete study procedures
结局指标
主要结局
Identification of air trapping and consolidation by EIT
时间窗: 36 months
The detection task for identifying air trapping and consolidation is to determine by inspection regions of EIT VQ index significantly lower than the surrounding lung region, with actual numbers or relative differences to be determined as part of this study in the correlation analysis to CT scans.
次要结局
- Determining utility of EIT information in response to treatment for a pulmonary exacerbation(36 months)
- Determination of structural changes in the lung by EIT(36 months)