Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording

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

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-11-30

Brief Summary

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The WIM-PC™ 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 infants that were hospitalized as a result of asthmatic attack.

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Detailed Description

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Asthma is the most common cause of hospitalization for respiratory infection in infants under one year of age. About 1-2% of infants with bronchiolitis need to be hospitalized and approximately 8% of these children require intensive care. Pulmonary function tests in infants are objective, but require sedation, which is problematic in acutely ill infants. 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, but recording time can be extended as necessary, to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.

Karmel Sonix Ltd has developed the WIM-PC™ 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 infants that were hospitalized as a result of asthmatic attack.

Conditions

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Asthma, Bronchial

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Asthmatic subjects

WIM-PC™ device

Intervention Type DEVICE

wheeze detection during dynamic bronchial situations in infants

2

Healthy subjects

WIM-PC™ device

Intervention Type DEVICE

wheeze detection during dynamic bronchial situations in infants

Interventions

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WIM-PC™ device

wheeze detection during dynamic bronchial situations in infants

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Asthmatic or healthy subjects;
* Age up to 18 years;
* Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria

* Chest lesions (rush or deformity);
* Hemodynamic instability;
* Concurrent additional major illness.
* Concurrent participation in any other clinical study.
* Physician objection.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes