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Sponsored by: |
KarmelSonix Ltd. |
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Information provided by: | KarmelSonix Ltd. |
ClinicalTrials.gov Identifier: | NCT00640120 |
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.
Condition | Intervention |
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Asthma, Bronchial |
Device: WIM-PC™ device |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording |
Estimated Enrollment: | 40 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Asthmatic subjects
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Device: WIM-PC™ device
wheeze detection during dynamic bronchial situations in infants
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2
Healthy subjects
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Device: WIM-PC™ device
wheeze detection during dynamic bronchial situations in infants
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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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
asthmatic subjects or healthy subjects
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Bnei-Zion Medical Center | Recruiting |
Haifa, Israel, 31048 | |
Contact: Hanna Levy, PhD (972)-4-638-8837 hanna@qsitemed.com | |
Principal Investigator: Amir Kugelman, MD |
Study Director: | Noam Gavriely, Prof. | unaffiliated |
Responsible Party: | KarmelSonix Ltd ( Dr. Hanna Levy ) |
Study ID Numbers: | KSI-WZK-01 |
Study First Received: | March 15, 2008 |
Last Updated: | July 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00640120 History of Changes |
Health Authority: | Israel: Ethics Commission |
wheeze detection |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |