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

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-12-31

Brief Summary

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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 WIM-PC™ device for wheeze detection during dynamic bronchial situations in asthmatic adult.

Detailed Description

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Asthma is defined by the National Asthma Education and Prevention Program (NAEPP) guideline as a 'Chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The asthma guideline states that inflammation causes recurrent episodes of wheezing, breathlessness and chest tightness that are associated with widespread but variable airflow obstruction.

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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Asthma, Bronchial

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Asthmatic subjects

PulmoTrack® 2010 with WIM-PC™ Technologies

Intervention Type DEVICE

wheeze detection during dynamic bronchial situations in infants

2

Healthy subjects

PulmoTrack® 2010 with WIM-PC™ Technologies

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Asthmatic or healthy subjects;
* 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

* Chest burns;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KarmelSonix Ltd.

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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Israel

Facility Contacts

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Hanna Levy, PhD

Role: primary

(972)-4-638-8837

Other Identifiers

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KSI-WZA-01

Identifier Type: -

Identifier Source: org_study_id

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