Realization of Spirometry Measurement Using Electrical Impedance Tomography (EIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- FVC
研究概览
简要总结
The main aim of this study is to test spirometry measurements using EIT with a calibration using tidal volume obtained from the simultaneous standard spirometry measurement. Another goal is to compare, based on the calibration, the spirometry parameters obtained from separate measurements using EIT and the standard spirometry using a pneumotachograph.
All spirometry measurements will be conducted in accordance with the latest available standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from the year 2005, including their emendation from 2017.
详细描述
Adding the pneumotachograph and antibacterial filter to the respiratory system can lead to increased dead space, flow resistance, and change the respiratory pattern. All of these negative features and reduced patient co-operation affect the measured results and their interpretation. The aim of this study is to test spirometry measurement using EIT and evaluate such spirometry parameters as forced vital capacity (FVC), forced expiratory volume exhaled in the first second of a forced expiration (FEV1) and ratio of FEV1/FVC called Tiffeneau index (TI) based on recalculation using the calibration constant. The study will be conducted using Ergostik (Geratherm, Germany) spirometer and EIT system Pulmovista 500 (Dräger, Germany).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females > 18 years old
- •Signed informed consent has been obtained
排除标准
- •Pregnancy
- •Cardiac pacemakers
- •Electrically active implant
- •Critical illness
- •Intrathoracic metal implants
- •Value of body mass index (BMI)>50
研究组 & 干预措施
Simultaneous standard spirometry and EIT
Simultaneous measurement by spirometer and EIT
干预措施: Simultaneous measurement by spirometer and EIT (Device)
Standard spirometry
Standard spirometry measurement with a pneumotachograph alone.
EIT alone
Spirometric examinations realized using the EIT
干预措施: Spirometric examinations realized using the EIT (Device)
结局指标
主要结局
FVC
时间窗: through study completion, an average of 1 year
forced vital capacity (L)
TI
时间窗: through study completion, an average of 1 year
ratio of FEV1/FVC called Tiffeneau index (-)
FEV1
时间窗: through study completion, an average of 1 year
forced expiratory volume exhaled in the first second of a forced expiration (L)
次要结局
未报告次要终点