Skip to main content
OpenTrials
Completed

NCT Number: NCT00640120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bnei-Zion Medical Center

Haifa, 31048, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WIM-PC™ device

Device

wheeze detection during dynamic bronchial situations in infants

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

KarmelSonix Ltd.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 21, 2008
Registry last updated
Jun 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.