Assessment of Cough and Wheeze With Breath Sound Documenting Device
|ClinicalTrials.gov Identifier: NCT00711399|
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : September 14, 2010
|Condition or disease||Intervention/treatment|
|Respiratory Sounds||Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies|
Clinical background Respiratory wheezes are a characteristic symptom of asthma and other obstructive diseases. The wheezes can be heard on the chest surface and on the trachea using a stethoscope or by listening near the person's mouth. The wheezes are a part of the Continuous Adventitious Breath Sounds (CABS) family, in addition to the wheezes, the rhonchi and the whistles are also a part of this family. Each breath sound has its own unique characteristics but all of them indicate a presence of an airway obstruction. Reducing the obstruction by bronco dilators, for example, lowers the amount of wheezes; meaning lowers the time period during the breathing when wheeze is present.
Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.
Children with respiratory infection, asthmatic children and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
Recently a breakthrough in continuous monitoring of respiratory symptoms was introduced. The Wheezing Infant Monitor (WIM) is a technology that utilizes a flat coin shape microphone that is attached to the chest and over the trachea and allows a continuous recording of the breath sounds absorbed by the microphone. This innovative technology provides an objective assessment of the duration, intensity and timing of the respiratory symptoms after a computerized processing of the data.
Study background The study title is 'Use of objective cough counting and breath sounds documenting device, to assess the severity and duration of cough and wheeze in children and adults suffer from acute or chronic respiratory disease'. The study goal is to create a database of respiratory sounds recordings, to evaluate and validate the WIM technology and to evaluate the efficacy of a specific treatment by comparing the severity of the respiratory symptoms before and after the administration of the treatment.
The study is an open study. Each patient will be evaluated twice during each day of hospitalization. Each recording session will last about one hour and include 10 minutes of pre treatment recording, administration of the treatment and continuation of the recording. The patient will be treated according to his/her condition and the recording will not delay the administration of the treatment in urgent cases.
The study population will consist of children with respiratory infection, asthmatic children and CF patients who suffer from respiratory symptoms such as cough and/or shortness of breath. The study population will include approximately 200 patients.
Patients with cough, wheeze or shortness of breath and patients (or their parents/guardians) who gave their consent to participate in the study will be included. Subjects who are in respiratory distress, have skin lesions precluding attachment of sensors, subject with chest tubes and pregnant women will be excluded from the study.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Observational Model:||Case Control|
|Official Title:||Use of Objective Cough Counting and Breath Sounds Documenting Device, to Assess the Severity and Duration of Cough and Wheeze in Children and Adults Suffer From Acute or Chronic Respiratory Disease.|
|Study Start Date :||September 2008|
|Primary Completion Date :||September 2009|
|Study Completion Date :||September 2010|
Device: PulmoTrack® 2010 with WIM-PC™ and WIM-CC™ Technologies
wheeze and cough detection in hospitalized patients.
- Respiratory sounds recordings [ Time Frame: 1 hour ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711399
|Carmel Medical Center|
|Haifa, Israel, 34362|
|Study Chair:||Yulia Goryachev, BSc||KarmelSonix Ltd.|