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临床试验/NCT01831713
NCT01831713终止不适用

Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure

Echosense Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年9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
200
试验地点
1
主要终点
Diagnose specific patterns of doppler signals in CHF patients

研究概览

简要总结

Historically, transthoracic Doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals. The ability to non-invasively collect information regarding the pulmonary aspect of the cardio-pulmonary system may provide valuable information and new insights into the structural and functional characteristics of the lung parenchyma and vasculature in health and disease states.

详细描述

This new system was previously studied among 31 healthy volunteers and one subject with atrial fibrillation.1 Pulsed spectral Doppler signals were obtained over the chest wall using a signal processing and algorithm package in conjunction with a non-imaging Doppler device coupled with an electrocardiogram. Clear reproducible lung Doppler signals (LDS) originating from different elements and phases of cardiac activity that generate mechanical waves which propagate throughout the lung were expressed in pulsatile changes in ultrasound reflections.

After the completion of the first 25 patients in our pilot study, we have received some valuable information. After assessing patients with CHF and pulmonary hypertension, we identified signals particular to the CHF group. There were unique features that were never observed in the normal patients. On top of the regular Lung Doppler signals seen in normal patients, high velocity "disorganized" variable signals that were not synchronous with the heart beat, but rather sometimes with respiration were observed. We believe that the signals may represent popping open of small bronchi surrounded by "water filled" parenchyma. These events that generate very strong reflector like signals may represent the movement of fluid at the blood vessel-alveolar air junction.

研究设计

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

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria
  • Age over 50 years
  • Belongs to one of the following categories:
  • A. Decompensated CHF: patients with overt pulmonary congestion or pulmonary edema on admission, evident both clinically and by chest x-ray. Patients may be with or without a Swan-Ganz catheter.
  • B. Compensated CHF: patients with significant CHF (NYHA II-IV) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission.
  • C. Non-CHF controls: patients without CHF and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension.
  • Signed Informed Consent

排除标准

  • Chronic obstructive pulmonary disease (COPD) Asthma Interstitial lung disease Any other obstructive or restrictive lung diseases Pneumonia- currently or in the past 3 months prior to inclusion Current or past pulmonary embolism Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Right sided pleural effusion that is not mild Severe kyphosis, scoliosis or chest wall deformity

结局指标

主要结局

Diagnose specific patterns of doppler signals in CHF patients

时间窗: December 2013

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 (1)

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