Bedside ultrasound of the IVC to find pulmonary edema in adults with sudden severe breathlessness

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

This project will test whether bedside ultrasound measurements of how the inferior vena cava changes with breathing can help identify pulmonary edema in adults who come to the emergency department with sudden breathing failure.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro (Academic / other)
• Locations: 1 site (Novara)
• Trial ID: NCT07324980 on ClinicalTrials.gov

What this trial studies

This is a single-center, prospective observational study enrolling adults who present to the emergency department with acute dyspnea and respiratory failure. Participants receive standardized clinical and laboratory evaluation plus multimodal point-of-care ultrasound (IVC, lung, and focused cardiac ultrasound) at admission, after about 1 hour, and again at 24–48 hours when feasible. The primary aim is to measure the diagnostic accuracy of respiratory variation in IVC diameter for identifying acute pulmonary edema. Secondary aims include whether combining IVC data with lung and cardiac ultrasound and selected lab variables improves diagnostic performance and prognostic stratification.

Who should consider this trial

Good fit: Adults (≥18 years) who present to the ED with acute dyspnea and respiratory failure (for example low PaO2, SpO2 <90% on room air, or PaO2/FiO2 <300), able to provide consent and not requiring invasive mechanical ventilation at initial stabilization.

Not a fit: Patients with inadequate ultrasound windows, acute respiratory failure from chest trauma, cardiac arrest at presentation, or those who require invasive mechanical ventilation during initial ED stabilization are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could enable faster, noninvasive bedside detection of pulmonary edema and support earlier targeted treatment and better risk stratification.

How similar studies have performed: Prior studies using lung and focused cardiac ultrasound have shown promise for detecting pulmonary edema, but evidence for IVC respiratory variation in the very early ED setting is mixed and not definitive.

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.

Where this trial is running

Novara

• Azienda Ospedaliero-Universitaria Maggiore della Carità — Novara, Italy (Recruiting)

Study contacts

• Study coordinator: Francesco Gavelli, MD, PhD

Conditions Hydrostatic Pulmonary Edema; Acute Respiratory Failure; Dyspnea