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

Official title

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

Overview

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.

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.

Primary outcome measures

• Diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter for acute pulmonary edema [Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)]

Secondary outcome measures (2)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Italy · 1 center

• Azienda Ospedaliero-Universitaria Maggiore della Carità — Novara

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/s12245-024-0069 PMID 39237860

Identifiers

NCT: NCT07324980 · CE218/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗