Evaluation of Acute Cardiogenic Dyspnoea With Thorax Echography and Pro-BNP in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 1
- 主要终点
- Diagnostic Outcome (Reference Standard)
研究概览
简要总结
LUNG ULTRASOUND IN THE MANAGEMENT OF DISPNEIC PATIENTS IN EMERGENCY DEPARTMENT
Introduction
This is a prospective randomized trial realized in the Emergency Department of the University Hospital of Siena, Italy.
Dyspnea is one of the most common causes worldwide of admission to the Emergency Department (ED) and acute heart failure (AHF) is a major cause of serious morbidity and death in such population, above all in elderly patients. Incidence rate is significantly higher in men than in women, in Europe it increases with age from 1.4/1000 person-years in subjects aged 55-59 years to 47.4/1000 person-years in those aged 90 years or older. The age-adjusted prevalence of AHF in the United States averages 36 cases per 100,000 of the population and accounts for 10,000 deaths annually.
In clinical practice this symptomatology is usually investigated in the pre-hospital phase only with history and physical examination; in the ED blood gas analysis (BGA), laboratory tests and chest X-rays can be performed as primary exams. BNP and NT pro-BNP are now considered reliable biochemical markers to distinguish cardiogenic from pulmonary etiology, both for their diagnostic and prognostic value. On the other hand, these biomarkers are affected by a "grey zone" of uncertainty, they are not available in all hospitals and their dosage samples are expensive: thus we propose other tools to support the diagnostic process.
详细描述
THE RATIONALE OF THE STUDY
It is widely reported in literature that ultrasound can identify the presence of interstitial and pulmonary alveolar syndrome by comet tail artifact with good sensitivity and specificity. This is an easy technique to perform and interpret, readily available and repeatable over time and executable bedside even in emergency situations. The execution of this investigative technique in the ED and also in a pre-hospital setting would provide additional and reliable information for patients with dyspnea, so favoring rapid identification of the etiology.
Accepting these observations, lung ultrasound (LUS) could have a central role in the evaluation of patients with shortness of breath in ED. Even the LUS in many studies has been considered useful for detecting pulmonary alterations, there are few data regarding its utilization in clinical practice and there is a lack of evidences concerning validated operative protocols. On this basis, it was decided to evaluate the employment of LUS in the ED with a structured and practical protocol.
ETHICAL ASPECTS
This study will be conducted according to Helsinki Declaration and i twill be approved by our Local Ethics Committee.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •All the patients admitted to our Emergency Department from January 2011 to February 2013 with acute non-traumatic dyspnea. We included patients carried by ambulance and patients who came autonomously.
排除标准
- •Age <18 years
- •Post-traumatic dyspnea
结局指标
主要结局
Diagnostic Outcome (Reference Standard)
时间窗: 1 day
Since a uniform reference test is lacking for acute heart failure, we chose to use a consensus diagnosis as formal reference standard, in analogy with earlier studies and as recommended by recent diagnostic research guidelines. An independent panel of experts (made up of two cardiologists and one senior emergency physician) judged all the collected data for each patient to determine the final diagnosis. The panel of experts assessed acute heart failure diagnosis following the criteria and approach outlined by the ESC Heart Failure Guidelines.
次要结局
未报告次要终点
研究者
Marcellopastorelli
Pastorelli
Comitato Etico di Area Vasta Sud Est