Non-invasive Heart Failure Monitoring Using Novel Acceleration Sensors System

Rambam Health Care Campus

Status: Unknown

Conditions: Heart Failure

Treatments: Device: "Pneumedicare"s monitoring system; Device: "Pneumedicare"s monitoring system.

Study type: Interventional

Funder types: Other

Identifiers

NCT01377350

0550-10ctil

ministry of health Israel (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to explore 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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute decompensated HF
• Decompensated chronic HF in patients with NYHA class III-IV symptoms
• Age over 20 years
• Ejection fraction reduced below 35% OR doppler evidence of impaired left ventricular diastolic filling

Exclusion criteria

• Inability or unwillingness to follow the study protocol

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

"Pneumedicare"s monitoring system

Experimental group

Description:

Single arm study - "Pneumedicare"s monitoring system is used for monitoring heart failure patients

Treatment:

Device: "Pneumedicare"s monitoring system.

Device: "Pneumedicare"s monitoring system