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

Completed

• Conditions: Asthma, Bronchial
• Interventions: Device: WIM-PC™ device

• Registration Number: NCT00640120
• Lead Sponsor: KarmelSonix Ltd.

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.

Study Timeline

• Status Verified: 2008-03
• Study First Submitted: 2008-03-15
• Study First Submitted QC: 2008-03-17
• Study First Posted: 2008-03-21
• Study Start: 2008-07
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Last Update Submitted: 2011-06-08
• Last Update Posted: 2011-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	WIM-PC™ device	Asthmatic subjects
2	WIM-PC™ device	Healthy subjects

Primary Outcome Measures

Name	Time	Method
Study success will be declared if one of the following is met: A correlation of at least 0.25 (R2=0.25) will be found between WR and FEV1 measurements; A correlation of at least 0.7 will be found between clinical parameter and WZ measurements.	6 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of the safety of using the WIM-PC™ for wheeze detection. Safety will be established by lack of adverse events. Since this is a Non Significant Risk (NSR) device serious adverse events are not expected	6 months

Trial Locations

Locations (1)

Bnei-Zion Medical Center; 🇮🇱 Haifa, Israel