Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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Recruitment Status : Withdrawn (Other strategies followed)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
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

Tracking Information
First Submitted Date  ICMJE August 25, 2014
First Posted Date  ICMJE August 28, 2014
Last Update Posted Date February 3, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02228018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Electronic Auscultation Coupled With CALSA and FRI; Repeatability of FRI Biomarkers
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Asthma
Intervention  ICMJE Device: CT-scan
CT-Scan will be taken at visit 1 on FRC and TLC breathing levels
Study Arms  ICMJE Experimental: CALSA and FRI repeatability
CT-Scan No medication used
Intervention: Device: CT-scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2014)
10
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02228018
Other Study ID Numbers  ICMJE FLUI-2014-118
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party FLUIDDA nv
Study Sponsor  ICMJE FLUIDDA nv
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
PRS Account FLUIDDA nv
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP