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临床试验/NCT03243773
NCT03243773已完成不适用

Evaluation of Lung UltraSound In Acute Heart Failure (ELUSIA)

Prof. Dr. Jörg Leuppi1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Value of lung ultrasound in the diagnosis of acute heart failure

研究概览

简要总结

Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain.

The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. Further goals are to evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary disease) and to compare demographics and clinical characteristics in different patient populations.

300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as principal complaint will undergo initial clinical assessment of the likely etiology of dyspnea by the ER physician in charge. The second assessment by the same physician will include results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold Standard") will be done by two experienced investigators after patient discharge taking into account the complete medical record except the results of lung ultrasound. Assessment of chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all other results.

详细描述

Evaluation of Lung Ultrasound in Acute Heart Failure (ELUSIA). A monocenter, randomised, double-blind, diagnostic clinical study.

Background and Rationale: Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain.

Objective(s): 1) To evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. 2) To evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray. 3) To compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary disease. 4) To compare demographics and clinical characteristics in different patient populations.

Inclusion criteria: Emergency room presentation with acute dyspnoe as principal complaint (either new or worsening in the last 48 hours), age ≥18 years.

Exclusion criteria: Immediately life threatening condition (cardiac arrest, ST-elevation myocardial infarction, shock, respiratory failure requiring intubation), no consent.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Value of lung ultrasound in the diagnosis of acute heart failure

时间窗: at the time of inclusion into the study

Presence/Absence of heart failure

次要结局

未报告次要终点

研究者

发起方
Prof. Dr. Jörg Leuppi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Jörg Leuppi

Institutional Head

Cantonal Hosptal, Baselland

研究点 (1)

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