跳至主要内容
临床试验/NCT03998410
NCT03998410终止不适用

Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

Echosense Ltd.6 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
130
试验地点
6
主要终点
Accuracy of diagnosis

研究概览

简要总结

The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

详细描述

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge.

Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests.

Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥ 18 years
  • Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
  • Patients designated to undergo chest X-ray as part of standard of care assessment.

排除标准

  • Obvious trauma contributing to dyspnea
  • Inability to provide written informed consent
  • Not speaking English or Spanish
  • Right-sided lobectomy
  • Patients with implanted ventricular assist device
  • Patient is unable to undergo the TPD test
  • Patient is already enrolled in a clinical study with experimental medications

结局指标

主要结局

Accuracy of diagnosis

时间窗: Average of 1 year

overall accuracy of the TPD system for the determination of ADHF causing acute dyspnea in an ED setting versus the gold standard (GS) diagnosis as determined by the final adjudicated diagnosis

次要结局

  • Sensitivity, Specificity, PPV, NPV of TPD diagnosis(Average of 1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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