Computerized Lung Sound Analysis

Pulmonary Fibrosis Clinical Trial

— CLSA  

Official title:

Computerized Lung Sound Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771184
• Other study ID #: 28-088 ex 15/16
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: May 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Pulmonary Fibrosis
• Respiratory Sounds

Intervention

Device:
• Lung Sound Recording System
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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Smolle-Juettner Freyja, Prof MD	Graz University of Technology

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 Seconds