Computerized Lung Sound Analysis (CLSA)

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Pulmonary Fibrosis
• Intervention / Treatment: Device: Lung Sound Recording System

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8010
    • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lung-Healthy; Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System.	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.
Other: Pneumothorax; Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System.	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.
Other: Pulmonary Fibrosis; Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Smolle-Juettner Freyja, Prof MD
• Collaborators: Graz University of Technology
• Investigators: Principal Investigator: Freyja-Maria Smolle-Juettner, Univ.-Prof., Medical University of Graz

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Signs and Symptoms, Respiratory; Pneumothorax; Pulmonary Fibrosis; Respiratory Sounds
• Other Study ID Numbers: 28-088 ex 15/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO