Full Text View
Tabular View
No Study Results Posted
Related Studies
Wheeze Detection in Children During Dynamic Bronchial Situations Measured by WIM-PC™ Recording
This study is currently recruiting participants.
Verified by KarmelSonix Ltd., March 2008
First Received: March 15, 2008   Last Updated: July 26, 2008   History of Changes
Sponsored by: KarmelSonix Ltd.
Information provided by: KarmelSonix Ltd.
ClinicalTrials.gov Identifier: NCT00640120
  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: Case Control, 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: November 2008
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640120

Locations
Israel
Bnei-Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Hanna Levy, PhD     (972)-4-638-8837     hanna@qsitemed.com    
Principal Investigator: Amir Kugelman, MD            
Sponsors and Collaborators
KarmelSonix Ltd.
Investigators
Study Director: Noam Gavriely, Prof. unaffiliated
  More Information

No publications provided

Responsible Party: KarmelSonix Ltd ( Dr. Hanna Levy )
Study ID Numbers: KSI-WZK-01
Study First Received: March 15, 2008
Last Updated: July 26, 2008
ClinicalTrials.gov Identifier: NCT00640120     History of Changes
Health Authority: Israel: Ethics Commission

Keywords provided by KarmelSonix Ltd.:
wheeze detection

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on September 10, 2009