Electrical Impedance Tomography of Lung in Child and Young Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
研究概览
简要总结
The investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group.
详细描述
The aim of the present study is verification of the correlation between EIT-derived data and following extracted parameters of the pulmonary function:
- forced expiratory volume in 1 second (FEV 1)
- forced vital capacity (FVC)
- relative forced expiratory volume in 1 second (FEV1/FVC)
- maximal expiratory flow (MEF 25)
- total lung capacity (TLC)
- resistance (Raw).
These findings could bring out new prospective opportunity for pulmonary function tests without cooperation.
Furthermore, the study aims to clarify whether EIT technique can be used for regional pulmonary function testing.
In addition, dynamic lung function parameter and static radiological techniques will be correlated with EIT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients: children and teenagers with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive brochitis, obstructive pneumonia).
- •Probands: Children and Teenager of 5-18 years without known obstructive pulmonary diseases
排除标准
- •active implants (ICD, CRT)
- •metal in chest
- •artificial heart valve
- •children < 5 years
- •pregnant and lactating females
- •Persons, who are in relationship of dependence to the investigator / sponsor
- •Persons, who are not able to understand and follow the instructions of the study personnel.
- •Lack of signed informed consent (by legal guardian /proband)
结局指标
主要结局
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
时间窗: Baseline
The robustness of ΔZFEV1.0 (= change in electrical impedance based on the FVC FEV1.0) and τ (= mechanical time constant τ which classifies the regional and global lung mechanics) and their clinical relevance will be investigated.
次要结局
- Correlation between lung function parameters and extracted parameters of the EIT.(Baseline)
- EIT as a diagnostic method for assessment of lung function(Baseline)
- Regional mechanical transmission behavior(Baseline)