Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01377350|
Recruitment Status : Unknown
Verified March 2011 by Rambam Health Care Campus.
Recruitment status was: Not yet recruiting
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: "Pneumedicare"s monitoring system. Device: "Pneumedicare"s monitoring system||Not Applicable|
Pulmonary veins congestion and fine changes in alveolar transudative effusion accumulation affect lung mechanics (compliance) and the respiratory effort. Moreover, the associated state of oxygen de-saturation is compensated by an increase in the respiratory effort. These changes in the respiratory effort are reflected in chest wall dynamics and may provide the earliest non-invasive sign for lung congestion and deterioration in the heart failure.
The research system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation. The signals are acquired by a miniaturized device that amplifies and samples the signals, stores and analyzes the data and displays the trends on the screen.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Experimental: "Pneumedicare"s monitoring system
Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients
Device: "Pneumedicare"s monitoring system.
50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.
Other Name: "Pneumedicare"s monitoring system for heart failure patientsDevice: "Pneumedicare"s monitoring system
Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.
Other Name: "Pneumedicare"s monitoring system for heart failure patients
- earliest non-invasive signs for lung congestion and deterioration in the heart failure [ Time Frame: 18 months ]Exploring the feasibility of monitoring hemodynamic changes, which result from heart failure exacerbations, by recording the respiratory effort, chest wall dynamics and quantifying the development of dyspnea by using miniature mechanical sensors that are attaches to the chest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377350
|Contact: Shmuel rispler, MD PhDemail@example.com|
|Contact: Amir Landesberg, MD PhD||972-505482249||Amir@bm.technion.ac.il|
|Rambam Health Care Campus||Not yet recruiting|
|Haifa, Israel, 31096|
|Contact: Shmuel Rispler, MD PhD 972-4-8542180 firstname.lastname@example.org|
|Contact: Amir Landesberg, MD PhD 972-505482249 Amir@bm.technion.ac.il|
|Principal Investigator: Shmuel Rispler, MD PhD|
|Principal Investigator:||Shmuel Rispler, MD PhD||Rambam Medical Center Haifa Israel|