Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound (DYSP-ED-US)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspnea; Acute Respiratory Failure; Hydrostatic Pulmonary Edema

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Francesco Gavelli, MD, PhD; Phone Number: +3903213733097; Email: francesco.gavelli@uniupo.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Azienda Ospedaliero-Universitaria Maggiore Della Carita
    • Contact: Francesco Gavelli, MD, PhF; Email: francesco.gavelli@uniupo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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 < 300.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At emergency department admission (baseline, T0) and after 1 hour (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At emergency department admission (baseline, T0) and after 1 hour (T1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At emergency department admission (baseline, T0) and after 1 hour (T1)

Collaborators and Investigators

• Sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro

Publications and helpful links

General Publications

• Gavelli F, Castello LM, Monnet X, Azzolina D, Nerici I, Priora S, Via VG, Bertoli M, Foieni C, Beltrame M, Bellan M, Sainaghi PP, De Vita N, Patrucco F, Teboul JL, Avanzi GC. Decrease of haemoconcentration reliably detects hydrostatic pulmonary oedema in dyspnoeic patients in the emergency department - a machine learning approach. Int J Emerg Med. 2024 Sep 5;17(1):114. doi: 10.1186/s12245-024-00698-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyspnea
• Other Study ID Numbers: CE218/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results are reported only in aggregated form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No