Computerized Lung Sound Analysis

NCT02771184 | Completed DMC

• 1 other identifier: 28-088 ex 15/16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Lung-Healthy

OTHER

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

Pneumothorax

OTHER

Subjects with pneumothorax. The intervention is the recording of lung sounds with the Lung Sound Recording System.

Device: Lung Sound Recording System

Pulmonary Fibrosis

OTHER

Subjects with pulmonary fibrosis. The intervention is the recording of lung sounds with the Lung Sound Recording System.

Device: Lung Sound Recording System

Interventions

Lung Sound Recording System DEVICE

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.

Lung-Healthy; Pneumothorax; Pulmonary Fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Smolle-Juettner Freyja, Prof MD: lead
• Graz University of Technology: collaborator

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Pneumothorax; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Lung Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Freyja-Maria Smolle-Juettner, Univ.-Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof. Dr.med.univ.

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 13, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)