Hydrostatic Pulmonary EdemaDYSP-ED-USNCT07324980
Acute DYSPnea in the Emergency Department: Diagnostic Value of Point-of-care UltraSound
An observational study of Hydrostatic Pulmonary Edema and Acute Respiratory Failure, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrostatic Pulmonary Edema, Acute Respiratory Failure, Dyspnea
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2025to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara, 28100
Francesco Gavelli, MD, PhF, francesco.gavelli@uniupo.it
About this study
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
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.
Read the 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.
- Medical subject headings
- Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At emergency department admission (baseline, T0) and after 1 hour (T1)
Secondary outcomes (2)
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
Measured: 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.
Measured: At emergency department admission (baseline, T0) and after 1 hour (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hydrostatic Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Gavelli, Università degli Studi del Piemonte Orientale Amedeo Avogadro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324980
- Sponsor's protocol ID
- CE218/2025
- Acronym
- DYSP-ED-US
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results are reported only in aggregated form.
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.
PubMed 39237860
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07324980
- Acronym / sponsor ID
- DYSP-ED-US / CE218/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università degli Studi del Piemonte Orientale Amedeo AvogadroUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Adults aged ≥18 years.
- Presentation to the emergency department with acute dyspnea and acute respiratory failure, defined by at least one of the following:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 39237860Gavelli 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.
- Individual participant dataSharing planned: No. Results are reported only in aggregated form.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrostatic Pulmonary Edema and Acute Respiratory Failure, run by Università degli Studi del Piemonte Orientale Amedeo Avogadro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Gavelli, MD, PhD (+3903213733097, francesco.gavelli@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07324980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.