The Comparison of Electronic Auscultation Coupled With Computer Aided Lung Sound Analysis (CALSA) and Functional Respiratory Imaging (FRI) and Repeatability of FRI Biomarkers in Healthy Subjects and Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- CALSA
研究概览
简要总结
CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.
详细描述
his is a study with no investigational product. CALSA will be compared with FRI and the repeatability of the FRI parameters will be tested in a group of healthy volunteers and asthma patients.
Electronic auscultation of respiratory sounds will be performed, lung function tests (at maximal dilatation) will be executed and computed tomography (CT) scans of the thorax will be taken. The scans will be taken at two different breathing levels, more specifically at total lung capacity (TLC) and functional residual capacity (FRC) level. The scans will be taken while the patient/ volunteer lies down on the movable table of the CT-scan. After the scan is taken it will be asked to the patient/ volunteer to sit upright on the scanning table and to lie down again. When the patient/ volunteer lies down a second CT-scan (TLC and FRC) will be taken.
The objective of this study is to compare CALSA with FRI and to assess the repeatability of FRI biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patient / volunteer ≥ 18 years old
- •Written informed consent obtained
- •The subject belongs to 1 of the following groups in the opinion of the investigator:
- •Group 1: healthy volunteer Group 2: patient with asthma
- •Only if patient/ volunteer is a female of childbearing potential: Confirmation that a contraception method was used at least 14 days before visit 1
排除标准
- •Pregnant or lactating female
- •Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
- •Patient/ volunteer with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study.
结局指标
主要结局
CALSA
时间窗: 1 day
The primary objective of this study is to compare CALSA with FRI. The respiratory sounds recordings are performed with a digital stethoscope and connected to the sound card of a laptop with commercial software, suitable for data acquisition. The respiratory sounds recordings are conducted in accordance with the Computerized Respiratory Sound Analysis guidelines (CORSA) for short-term acquisition. Subjects are asked to breathe through the mouth in a sitting position (tidal breathing) during the recordings. Three sets of recordings are made for 7 - 10 respiratory cycles with a maximum duration of 25 seconds.
次要结局
- Total Airway Volume (iVaw)(1 day)
- Total Airway Resistance (iRaw)(1 day)
- Internal Airway Distribution(1 day)
- Lobar Volume(1 day)