Clinical trial NCT00640120: Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording
Official title: Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma, Bronchial
Keywords: wheeze detection
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asthmatic subjects or healthy subjects

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center
Study officials:
name: Noam Gavriely, Prof.
role: STUDY_DIRECTOR
References: