Trials / Completed
CompletedNCT00640120
Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- KarmelSonix Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WIM-PC™ device | wheeze detection during dynamic bronchial situations in infants |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2008-03-21
- Last updated
- 2011-06-09
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT00640120. Inclusion in this directory is not an endorsement.