Computerized Lung Sound Analysis

NCT ID: NCT02771184

Last Updated: 2019-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-03-31

Brief Summary

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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

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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.

Conditions

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Pneumothorax Pulmonary Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lung-Healthy

Subjects with no diagnosed lung disease. The intervention is the recording of lung sounds with the Lung Sound Recording System.

Group Type OTHER

Lung Sound Recording System

Intervention Type 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.

Pneumothorax

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

Group Type OTHER

Lung Sound Recording System

Intervention Type 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.

Pulmonary Fibrosis

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

Group Type OTHER

Lung Sound Recording System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Graz University of Technology

OTHER

Sponsor Role collaborator

Smolle-Juettner Freyja, Prof MD

OTHER

Sponsor Role lead

Responsible Party

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Smolle-Juettner Freyja, Prof MD

Univ.-Prof. Dr.med.univ.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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28-088 ex 15/16

Identifier Type: -

Identifier Source: org_study_id

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