Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00640120
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2008-03-15
Brief Title:
Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC Recording
Sponsor:
KarmelSonix Ltd
Organization:
KarmelSonix Ltd
Study Overview
Official Title:
Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC Recording
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None