Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07324980

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria Maggiore della Carità

Novara, 28100, Italy

Location status: Recruiting

Location contact

Francesco Gavelli, MD, PhF

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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 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

  2. Diagnostic performance of early changes in plasma protein concentration

    Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)

    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.

Other outcomes

  1. Diagnostic performance of multimodal ultrasound-clinical integration

    Time frame: At emergency department admission (baseline, T0) and after 1 hour (T1)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Gavelli, MD, PhD

CONTACT

[email protected]

+3903213733097

Sponsors and collaborators

Lead sponsor

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Other

Registry information

Official study title

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

Acronym: DYSP-ED-US

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.