Clinical trial NCT00644462: Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording
Official title: Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma, Bronchial
Keywords: wheeze detection
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asthmatic subjects or healthy subjects

Brief summary: The PulmoTrack® 2010 with WIM-PC™ Technologies 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 asthmatic adult.

Detailed description: Asthma is defined by the National Asthma Education and Prevention Program (NAEPP) guideline as a 'Chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The asthma guideline states that inflammation causes recurrent episodes of wheezing, breathlessness and chest tightness that are associated with widespread but variable airflow obstruction.

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 to obtain good quality data, where wheezes are detected and counted with high degree of accuracy.

Karmel Sonix Ltd has developed the PulmoTrack® 2010 with WIM-PC™ Technologies 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 PulmoTrack® 2010 with WIM-PC™ Technologies device for wheeze detection during dynamic bronchial situations in asthmatic adults.

Eligibility criteria: Inclusion Criteria:

* Asthmatic or healthy subjects;
* Age 18 and up;
* Not smoking for at the last two years;
* Subject or subject's parents/guardian is able to comprehend and give informed consent for participation in the study.

Exclusion Criteria:

* Chest burns;
* COPD;
* Pregnant or lactating;
* Mechanically ventilatory;
* Homodynamic instability;
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening;
* Acute infection requiring intravenous antibiotics at the time of screening;
* Uncontrolled bleeding and coagulation disorders;
* Uncontrolled diabetes mellitus: IDDM or NIDDM;
* HIV positive or any other immunosuppressive disorder;
* Subject objects to the study protocol;
* 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 PulmoTrack® 2010 with WIM-PC™ Technologies 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: 1 hour
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center
Study officials:
name: Noam Gavriely, Prof.
role: STUDY_DIRECTOR
References: