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

This study has been completed.
Sponsor:
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT00640120
First received: March 15, 2008
Last updated: June 8, 2011
Last verified: March 2008
  Purpose

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.


Condition Intervention
Asthma, Bronchial
Device: WIM-PC™ device

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ 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 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Asthmatic subjects
Device: WIM-PC™ device
wheeze detection during dynamic bronchial situations in infants
2
Healthy subjects
Device: WIM-PC™ device
wheeze detection during dynamic bronchial situations in infants

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

Ages Eligible for Study:   up to 18 Years
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640120

Locations
Israel
Bnei-Zion Medical Center
Haifa, Israel, 31048
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: NCT00640120     History of Changes
Other Study ID Numbers: KSI-WZK-01
Study First Received: March 15, 2008
Last Updated: June 8, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by KarmelSonix Ltd.:
wheeze detection

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

ClinicalTrials.gov processed this record on October 21, 2014