Assessment of Cough and Wheeze With Breath Sound Documenting Device
NCT ID: NCT00711399
Last Updated: 2010-09-14
Study Results
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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COMPLETED
55 participants
OBSERVATIONAL
2008-09-30
2010-09-30
Brief Summary
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Detailed Description
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Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.
Children with respiratory infection, asthmatic children and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Recently a breakthrough in continuous monitoring of respiratory symptoms was introduced. The Wheezing Infant Monitor (WIM) is a technology that utilizes a flat coin shape microphone that is attached to the chest and over the trachea and allows a continuous recording of the breath sounds absorbed by the microphone. This innovative technology provides an objective assessment of the duration, intensity and timing of the respiratory symptoms after a computerized processing of the data.
Study background The study title is 'Use of objective cough counting and breath sounds documenting device, to assess the severity and duration of cough and wheeze in children and adults suffer from acute or chronic respiratory disease'. The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.
The study is an open study. Each patient will be evaluated twice during each day of hospitalization. Each recording session will last about one hour and include 10 minutes of pre treatment recording, administration of the treatment and continuation of the recording. The patient will be treated according to his/her condition and the recording will not delay the administration of the treatment in urgent cases.
The study population will consist of children with respiratory infection, asthmatic children and CF patients who suffer from respiratory symptoms such as cough and/or shortness of breath. The study population will include approximately 200 patients.
Patients with cough, wheeze or shortness of breath and patients (or their parents/guardians) who gave their consent to participate in the study will be included. Subjects who are in respiratory distress, have skin lesions precluding attachment of sensors, subject with chest tubes and pregnant women will be excluded from the study.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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group A
Study group
PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
wheeze and cough detection in hospitalized patients.
Interventions
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PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
wheeze and cough detection in hospitalized patients.
Eligibility Criteria
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Inclusion Criteria
* Patients with cough or shortness of breath
Exclusion Criteria
* Skin lesions precluding attachment of sensors
* Respiratory distress
* Pregnant women
1 Year
45 Years
ALL
No
Sponsors
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Carmel Medical Center
OTHER
Responsible Party
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Carmel Medical Center
Principal Investigators
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Yulia Goryachev, BSc
Role: STUDY_CHAIR
KarmelSonix Ltd.
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Related Links
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Breath sound recorder WIM-PC™
Other Identifiers
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CMC 07-0063
Identifier Type: -
Identifier Source: org_study_id