An observational study in Hydrostatic Pulmonary Edema, Acute Respiratory Failure and Dyspnea, sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Università degli Studi del Piemonte Orientale Amedeo Avogadro · Observational
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.
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.
656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.
This study's planned enrollment of 200 is above the median of 122 across 204 observational studies indexed under Dyspnea.
Browse Dyspnea studies →Università degli Studi del Piemonte Orientale Amedeo Avogadro is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the emergency department with acute dyspnea and acute respiratory failure, undergoing standard diagnostic evaluation and clinical management as part of routine care.
Presentation to the emergency department with acute dyspnea and acute respiratory failure, defined by at least one of the following:
Exclusion Criteria:
Diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter for acute pulmonary edema
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.
Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)
Diagnostic performance of early changes in hemoglobin concentration
Diagnostic performance of early variation in hemoglobin concentration - as a surrogate marker of fluid shifts - in discriminating acute pulmonary edema from other causes of acute dyspnea in the emergency department
Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)
Diagnostic performance of early changes in plasma protein concentration
Diagnostic performance of early variation in plasma protein concentration - as a surrogate marker of fluid shifts - in discriminating acute pulmonary edema from other causes of acute dyspnea in the emergency department.
Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)
Diagnostic performance of multimodal ultrasound-clinical integration
Diagnostic accuracy of integrated multimodal assessment combining inferior vena cava ultrasound, lung ultrasound, focused cardiac ultrasound, and selected clinical and laboratory variables for the diagnosis of acute pulmonary edema.
Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)
Plan to share: No — Results are reported only in aggregated form.
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Università degli Studi del Piemonte Orientale Amedeo Avogadro