The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
- Conditions
- Asthma
- Interventions
- Device: CT-scan
- Registration Number
- NCT02228018
- Lead Sponsor
- FLUIDDA nv
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CALSA and FRI repeatability CT-scan CT-Scan No medication used
- Primary Outcome Measures
Name Time Method CALSA 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.
- Secondary Outcome Measures
Name Time Method Total Airway Volume (iVaw) 1 day The secondary objective is to check the repeatability of the FRI parameters
Total Airway Resistance (iRaw) 1 day The secondary objective is to check the repeatability of the FRI parameters.
Internal Airway Distribution 1 day The secondary objective is to check the repeatability of the FRI parameters
Lobar Volume 1 day The secondary objective is to check the repeatability of the FRI parameters
Trial Locations
- Locations (1)
Antwerp University Hospital
🇧🇪Edegem, Antwerp, Belgium