Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by KarmelSonix Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT00644462
First received: March 20, 2008
Last updated: January 10, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Asthma, Bronchial
Device: PulmoTrack® 2010 with WIM-PC™ Technologies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Wheeze Detection in Adults During Dynamic Bronchial Situations Measured by PulmoTrack® 2010 With WIM-PC™ Technologies Recording

Resource links provided by NLM:


Further study details as provided by KarmelSonix Ltd.:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Asthmatic subjects
Device: PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants
2
Healthy subjects
Device: PulmoTrack® 2010 with WIM-PC™ Technologies
wheeze detection during dynamic bronchial situations in infants

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

asthmatic subjects or healthy subjects

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644462

Locations
Israel
Bnei-Zion Medical Center Not yet recruiting
Haifa, Israel, 31048
Contact: Hanna Levy, PhD    (972)-4-638-8837    hanna@qsitemed.com   
Principal Investigator: Naveh Tov, MD         
Sponsors and Collaborators
KarmelSonix Ltd.
Investigators
Study Director: Noam Gavriely, Prof.
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, KarmelSonix Ltd
ClinicalTrials.gov Identifier: NCT00644462     History of Changes
Other Study ID Numbers: KSI-WZA-01
Study First Received: March 20, 2008
Last Updated: January 10, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by KarmelSonix Ltd.:
wheeze detection

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014