The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02228018|
Recruitment Status : Withdrawn (Other strategies followed)
First Posted : August 28, 2014
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: CT-scan||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Experimental: CALSA and FRI repeatability
CT-Scan No medication used
CT-Scan will be taken at visit 1 on FRC and TLC breathing levels
- CALSA [ Time Frame: 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.
- Total Airway Volume (iVaw) [ Time Frame: 1 day ]The secondary objective is to check the repeatability of the FRI parameters
- Total Airway Resistance (iRaw) [ Time Frame: 1 day ]The secondary objective is to check the repeatability of the FRI parameters.
- Internal Airway Distribution [ Time Frame: 1 day ]The secondary objective is to check the repeatability of the FRI parameters
- Lobar Volume [ Time Frame: 1 day ]The secondary objective is to check the repeatability of the FRI parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228018
|Antwerp University Hospital|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Wilfried De Backer, MD, PhD||University Hospital, Antwerp|