Evaluation of Lung Doppler Signals in Patients Presenting to EMD

A. Study Purpose and Rationale To evaluate the LDS in patients with various acute cardiovascular and/or pulmonary disease states, in order to characterize these signals and assess their diagnostic utility in those acute conditions.

B. Study Design

The study design is an open, prospective, non-interventional study. 100 patients will be recruited at the Rambam Emergency Medicine Department (EMD) during an 18 month period.

Study population will consist of patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc. Following informed consent and applying the inclusion and exclusion criteria, the eligible patients will undergo routine physical examination including vital signs measurement (blood pressure, heart rate, respiratory rate, O2 saturation by pulse oximetry), and auscultation to lungs. The patient would also undergo ECG and chest X-ray as part of the routine evaluation. Blood tests and additional imaging procedures will be done according to clinical indication. Lung Doppler signals will be recorded from selected locations over the right chest wall, preferably in sitting or semi-reclining position (if patient's condition permits). The recordings will be repeated several times in the EMD to monitor the changes following treatment. In some cases, LDS recordings may also be repeated later in the EMD or other hospital wards when the patient recovers from the acute condition (usually towards the end of the hospital stay). The acquired Doppler data will be saved by PC for off-line processing and analysis using the special algorithms that have been developed for this purpose.

The medical charts of enrolled subjects will also be accessed to obtain study specific information. The information that will be collected includes (but is not limited to): date of birth, gender, height, weight, past medical history, medications, physical examination, ECG, blood tests, pulmonary function tests (including spirometry and lung volumes), chest X-ray/CT and Echocardiography results. The results of study tests and procedures will be disclosed to EchoSense Ltd.

Since the study is non-interventional, the TPD recordings will not be used to guide medical treatment decisions. TPD recordings will not interfere with administering optimal treatment to the patient, which is of first priority in all recruited subjects.

C. Study Device The lung Doppler signals will be acquired by the Sonara/tek Transcranial Doppler (TCD) system. This commercially available TCD system was approved by the Federal Drug Administration on November 3rd, 2006 as a 510k class II device. This device was approved as a means of measuring blood flow velocities within the brain as well as peripheral blood vessels. We will utilize this non-invasive Doppler system in an investigational manner to record the lung Doppler signals. The recorded signals will later be analyzed by the EchoSense signal processing package.