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

Asthma, Bronchial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640120
• Other study ID #: KSI-WZK-01
• Status: Completed
• Phase: N/A
• First received: March 15, 2008
• Last updated: June 8, 2011
• Start date: July 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2008
• Source: KarmelSonix Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Device:
• WIM-PC™ device
wheeze detection during dynamic bronchial situations in infants

Locations

Country	Name	City	State
Israel	Bnei-Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
KarmelSonix Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes