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临床试验/NCT01913457
NCT01913457终止不适用

Evaluation of Lung Doppler Signals in Pediatric and Adult Patients

Echosense Ltd.2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
230
试验地点
2
主要终点
Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern.

研究概览

简要总结

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 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.

Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization, which is considered the gold-standard, but is invasive.

In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients with PAH and control subjects.

One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups, with and without pulmonary vascular disease. The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Adults undergoing RHC:
  • Males or females aged over 18 years
  • With suspicion or diagnosis of pulmonary hypertension.
  • Scheduled to undergo right heart catheterization
  • Able and willing to give informed consent
  • Pediatric patients undergoing RHC:
  • Males or females aged 0-18 years
  • Scheduled to undergo right hear catheterization
  • Parents willing to give informed consent
  • Pediatric patients without significant cardio-pulmonary diseases:
  • Males or females aged 0-18 years Not known to have a significant cardiac or pulmonary disease
  • Legal guardians willing to give informed consent

排除标准

  • -Hemodynamically unstable patients.
  • For adult and pediatric patients undergoing right heart catheterization:
  • a. Any contra-indication to perform the procedure
  • For adults only:
  • Patients incapable of performing a Valsalva maneuver
  • Patients with recent (within the past 3 months) myocardial infarction, high degree AV block, severe aortic stenosis or open angle glaucoma

结局指标

主要结局

Diagnose specific pattern of LDS in children by features as velocity & power in comparison to adult LDS pattern.

时间窗: 1 year to collect all data and obtain an average diagnostic pattern

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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