Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversità degli Studi del Piemonte Orientale Amedeo Avogadro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥18 years.

PaO₂ < 60 mmHg on room air, or

Oxygen saturation (SpO₂) < 90% on room air, or

PaO₂/FiO₂ ratio < 300.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)

Other outcomes

1

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)

Sponsors and contacts

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