Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound (NCT07324980) | Clinical Trial Compass
RecruitingNot Applicable
Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound
Italy200 participantsStarted 2025-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of respiratory variation in inferior vena cava (IVC) diameter for acute pulmonary edema
Timeframe: At emergency department admission (baseline, T0) and after 1 hour (T1)
Trial details
NCT IDNCT07324980
SponsorUniversità degli Studi del Piemonte Orientale Amedeo Avogadro