跳至主要内容
临床试验/NCT07324980
NCT07324980招募中不适用

Acute Dyspnea in the Emergency Department: Diagnostic Evaluation of Inferior Vena Cava Ultrasound Integrated With Multimodal Point-of-Care Ultrasound and Clinical Data

Università degli Studi del Piemonte Orientale Amedeo Avogadro1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter for acute pulmonary edema

研究概览

简要总结

Acute dyspnea is a common reason for emergency department (ED) admission and is frequently caused by acute heart failure with pulmonary edema. Rapid differentiation between cardiogenic and non-cardiogenic causes of dyspnea is essential to guide early treatment and risk stratification. However, no single gold standard exists for the assessment of venous congestion in the acute setting.

This prospective observational study aims to evaluate the diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter measured by point-of-care ultrasound (POCUS) in identifying acute pulmonary edema in patients presenting to the ED with acute respiratory failure. In addition, the study investigates whether integration of IVC ultrasound with lung ultrasound, bedside cardiac ultrasound, and selected clinical and laboratory variables - such as hemoglobin and plasma protein changes - improves diagnostic performance and prognostic stratification.

详细描述

Acute heart failure is a leading cause of emergency department visits and hospital admissions and is associated with high morbidity, mortality, and healthcare costs. Dyspnea is the most frequent presenting symptom. Early identification of pulmonary edema and assessment of venous congestion are critical to optimize therapeutic decisions in the acute phase.

Ultrasound assessment of inferior vena cava (IVC) respiratory variation has been proposed as a rapid, non-invasive marker of volume overload and venous congestion. However, its reliability during the early stages of acute dyspnea remains uncertain, particularly in patients with increased respiratory effort. Other ultrasound-based approaches, including lung ultrasound, and focused cardiac ultrasound, provide complementary information on pulmonary congestion and cardiac function.

This single-center, prospective, observational study will enroll adult patients presenting to the emergency department with acute dyspnea and respiratory failure. All participants will undergo standardized clinical assessment, laboratory testing, chest imaging as per routine care, and multimodal point-of-care ultrasound evaluation at ED admission, after 1 hour, and at 24-48 hours when clinically feasible.

The primary objective is to assess the diagnostic accuracy of respiratory variation in IVC diameter for identifying acute pulmonary edema. Secondary objectives include evaluation of multimodal ultrasound-clinical scores for diagnostic and prognostic purposes and analysis of early changes in hemoglobin and plasma proteins as surrogate markers of fluid shifts. Clinical outcomes, including need for hospitalization, escalation of care, and in-hospital mortality, will be recorded.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adults aged ≥18 years.
  • Presentation to the emergency department with acute dyspnea and acute respiratory failure, defined by at least one of the following:
  • PaO₂ < 60 mmHg on room air, or
  • Oxygen saturation (SpO₂) < 90% on room air, or
  • PaO₂/FiO₂ ratio <
  • Ability to provide written informed consent or eligibility for deferred consent according to local regulations.
  • Undergoing standard diagnostic evaluation including laboratory tests and chest imaging as part of routine clinical care.

排除标准

  • Refusal to provide informed consent (or consent by legal representative when applicable).
  • Inadequate ultrasound window or technically insufficient ultrasound assessment.
  • Acute respiratory failure secondary to chest trauma.
  • Cardiac arrest at presentation or during emergency department stabilization.
  • Requirement for invasive mechanical ventilation during initial stabilization in the emergency department.

结局指标

主要结局

Diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter for acute pulmonary edema

时间窗: At emergency department admission (baseline, T0) and after 1 hour (T1)

Diagnostic performance of respiratory variation in inferior vena cava diameter, measured by point-of-care ultrasound (POCUS), in discriminating acute pulmonary edema from other causes of acute dyspnea in the emergency department.

次要结局

  • Diagnostic performance of early changes in hemoglobin concentration(At emergency department admission (baseline, T0) and after 1 hour (T1))
  • Diagnostic performance of early changes in plasma protein concentration(At emergency department admission (baseline, T0) and after 1 hour (T1))

研究者

发起方
Università degli Studi del Piemonte Orientale Amedeo Avogadro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Gavelli

Emergency Medicine Associate Professor

Università degli Studi del Piemonte Orientale Amedeo Avogadro

研究点 (1)

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