Evaluation of Lung Doppler Signals in Patients With Acute Cardiovascular or Pulmonary Conditions Presenting to the Emergency Medicine Department by a Modified Ultrasound Doppler TCD Device.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern
研究概览
简要总结
Historically, ultrasound has been unable to provide interpretable data from the lung parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by the air in the lungs. Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package (transthoracic parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general.
Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD and pulmonary hypertension, show promise regarding the diagnostic potential of the lung Doppler signals (unpublished data). However, lung Doppler signals in acute disease states were not investigated so far. It is reasonable to speculate that the pathological processes underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the TPD may have diagnostic potential in these conditions. For example, during acute pulmonary embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis without using ionizing radiation (as in CT or lung scan). Another example is COPD exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be attenuated by the increase of air volume in the lungs.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged over
- •Suspected or confirmed acute cardiovascular or pulmonary condition.
排除标准
- •Minor (aged < 18). People unwilling to give informed consent. Pregnant women.
结局指标
主要结局
Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern
时间窗: 1.5y to collect all data required to obtain a diagnostic pattern
次要结局
未报告次要终点