Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording
NCT ID: NCT00644462
Last Updated: 2009-01-13
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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UNKNOWN
50 participants
OBSERVATIONAL
2009-06-30
2009-12-31
Brief Summary
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Detailed Description
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Wheeze quantification by lung sounds analysis methods is objective, non invasive and has been shown to correlate with clinical status in asthma and bronchiolitis. The recording procedure is simple, requiring only the attachment of 4 ECG-size sensors to the chest wall. A 30-second recording is often adequate to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.
Karmel Sonix Ltd has developed the PulmoTrack® 2010 with WIM-PC™ Technologies device, indicated for acoustic pulmonary function measurement that quantifies the presence of wheezing. This study was designed in order to evaluate the efficacy and safety of using the PulmoTrack® 2010 with WIM-PC™ Technologies device for wheeze detection during dynamic bronchial situations in asthmatic adults.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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1
Asthmatic subjects
PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
2
Healthy subjects
PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
Interventions
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PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
Eligibility Criteria
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Inclusion Criteria
* Age 18 and up;
* Not smoking for at the last two years;
* Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.
Exclusion Criteria
* COPD;
* Pregnant or lactating;
* Mechanically ventilatory;
* Homodynamic instability;
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening;
* Acute infection requiring intravenous antibiotics at the time of screening;
* Uncontrolled bleeding and coagulation disorders;
* Uncontrolled diabetes mellitus: IDDM or NIDDM;
* HIV positive or any other immunosuppressive disorder;
* Subject objects to the study protocol;
* Concurrent participation in any other clinical study;
* Physician objection.
18 Years
ALL
Yes
Sponsors
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KarmelSonix Ltd.
INDUSTRY
Responsible Party
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KarmelSonix Ltd
Principal Investigators
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Noam Gavriely, Prof.
Role: STUDY_DIRECTOR
Locations
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Bnei-Zion Medical Center
Haifa, , Israel
Countries
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Facility Contacts
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Other Identifiers
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KSI-WZA-01
Identifier Type: -
Identifier Source: org_study_id
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