Computerized Lung Sound Analysis (CLSA)
Primary Purpose
Pneumothorax, Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Lung Sound Recording System
Sponsored by
About this trial
This is an interventional basic science trial for Pneumothorax
Eligibility Criteria
Inclusion Criteria:
General:
- Smoker and non-smoker
- 'Lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis
Additional for 'lung-healthy' subjects:
- COPD < 3 (GOLD Criteria)
Exclusion Criteria:
General:
- Body Mass Index > 30
- Preceding thoracic surgery
- Non-cooperation of the subject
- Intubated or tracheostomized subjects
Additional for 'lung-healthy' subjects:
- Disease of the respiratory system
- Taking medication influencing the respiration
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Lung-Healthy
Pneumothorax
Pulmonary Fibrosis
Arm Description
Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Outcomes
Primary Outcome Measures
16-Channel Lung Sound Recordings and synchronous Airflow Recording
The lung sounds and the airflow signal are simultaneously recorded with the Lung Sound Recording System. One time frame contains several breathing phases. Depending on the lung disease normal lung sounds are either altered or adventitious lung sounds are superimposed.
Secondary Outcome Measures
Full Information
NCT ID
NCT02771184
First Posted
April 22, 2016
Last Updated
May 16, 2019
Sponsor
Smolle-Juettner Freyja, Prof MD
Collaborators
Graz University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02771184
Brief Title
Computerized Lung Sound Analysis
Acronym
CLSA
Official Title
Computerized Lung Sound Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Smolle-Juettner Freyja, Prof MD
Collaborators
Graz University of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial is conducted within the research project 'Computerized Lung Sound Analysis'. The research goal is the development of a system enabling the automatic classification of lung sounds, which will result in a decision support system for physicians.
The objective of this trial is to create a small lung sound corpus, enabling the development of a prototype of the described system. Therefore, investigators record lung sounds with several lung sound transducers distributed on the posterior chest of human test subjects.
Detailed Description
In this clinical trial investigators record lung sounds over the posterior chest of human test subjects. The subjects are either lung-healthy (control group) or subjects with pneumothorax condition or pulmonary fibrosis. The lung sounds are recorded in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. For each subject investigators simultaneously record 30 seconds of the airflow signal and the lung sounds from 16 lung sound transducers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Pulmonary Fibrosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lung-Healthy
Arm Type
Other
Arm Description
Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Arm Title
Pneumothorax
Arm Type
Other
Arm Description
Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Arm Title
Pulmonary Fibrosis
Arm Type
Other
Arm Description
Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Intervention Type
Device
Intervention Name(s)
Lung Sound Recording System
Intervention Description
The lung sounds are recorded over the posterior chest in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. Therefore, they receive a real-time feedback for the airflow rate. The airflow signal and the lung sounds from 16 lung sound transducers are recorded simultaneously for 30 seconds.
Primary Outcome Measure Information:
Title
16-Channel Lung Sound Recordings and synchronous Airflow Recording
Description
The lung sounds and the airflow signal are simultaneously recorded with the Lung Sound Recording System. One time frame contains several breathing phases. Depending on the lung disease normal lung sounds are either altered or adventitious lung sounds are superimposed.
Time Frame
30 Seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
General:
Smoker and non-smoker
'Lung-healthy' subjects (control group), subjects with pneumothorax or subjects with pulmonary fibrosis
Additional for 'lung-healthy' subjects:
COPD < 3 (GOLD Criteria)
Exclusion Criteria:
General:
Body Mass Index > 30
Preceding thoracic surgery
Non-cooperation of the subject
Intubated or tracheostomized subjects
Additional for 'lung-healthy' subjects:
Disease of the respiratory system
Taking medication influencing the respiration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Freyja-Maria Smolle-Juettner, Univ.-Prof.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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