Computerized Lung Sound Analysis

Not Applicable

Completed

• Conditions: Pulmonary Fibrosis; Pneumothorax
• Interventions: Device: Lung Sound Recording System

• Registration Number: NCT02771184
• Lead Sponsor: Smolle-Juettner Freyja, Prof MD

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung-Healthy	Lung Sound Recording System	Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Pneumothorax	Lung Sound Recording System	Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System.
Pulmonary Fibrosis	Lung Sound Recording System	Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System.

Primary Outcome Measures

Name	Time	Method
16-Channel Lung Sound Recordings and synchronous Airflow Recording	30 Seconds	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.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria