High-flow nasal oxygen versus non-invasive positive‑pressure ventilation for acute cardiogenic pulmonary edema

Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support

This will try high‑flow nasal oxygen and non‑invasive positive‑pressure ventilation in adults with acute cardiogenic pulmonary edema to see which better supports breathing and right‑sided heart function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma)
• Trial ID: NCT05989139 on ClinicalTrials.gov

What this trial studies

Adults with acute cardiogenic pulmonary edema are randomized in a cross‑over design to receive non‑invasive positive‑pressure ventilation (NPPV) and high‑flow nasal cannula (HFNC), each applied for 40 minutes with evaluations before and after each period. Transthoracic echocardiography is used to measure right ventricular systolic function and RV strain, and other hemodynamic parameters are recorded. Physiological measures include mean arterial pressure, heart rate, respiratory rate, oxygen saturation and arterial blood gases, along with patient comfort and dyspnea relief. The single‑center trial is conducted at Fondazione Policlinico Universitario Agostino Gemelli in Rome.

Who should consider this trial

Good fit: Adults (≥18 years) presenting with acute cardiogenic pulmonary edema from causes such as myocardial infarction, acute myocarditis, severe valvular disease, or acute/chronic heart failure who can give informed consent and meet the protocol criteria.

Not a fit: Patients with hypercapnic respiratory failure, respiratory infection or consolidation, cardiogenic shock or hypotension, known right ventricular dysfunction, recent cardiac surgery, or severely impaired consciousness are excluded and unlikely to benefit from these interventions in this trial.

Why it matters

Potential benefit: If one method shows clearer improvements in right ventricular function and symptom relief, clinicians could choose the safer, more comfortable support quickly to improve short‑term patient outcomes.

How similar studies have performed: Non‑invasive ventilation has established benefit in cardiogenic pulmonary edema, while HFNC is a newer approach with limited but growing comparative data in this condition.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 y.o.;
* Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology (ESC) guidelines \[4\];
* Hypertensive crisis with systolic blood pressure \>200 mmHg;
* Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
* Written informed consent.

Exclusion Criteria:

* Age \<18 y.o.;
* Hypercapnia with respiratory acidosis (PaCO2 \> 45 mmHg with pH \< 7.35);
* History of fever in the previous 4 days;
* White blood cell count \> 12.000;
* Increased procalcitonin serum levels;
* Consolidative areas at chest radiograph;
* Hypotension (systolic blood pressure \< 85 mmHg);
* Cardiogenic shock;
* Right ventricular (RV) dysfunction;
* Previous cardiac surgery,
* Glasgow Coma Scale score ≤ 8 points;
* Impaired ability to protect the airway from aspiration;
* Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;
* Respiratory arrest;
* Severe hemodynamic instability;
* Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.

Where this trial is running

Roma

• Fondazione IRCCS Policlinico Agostino Gemelli Roma — Roma, Italy (RECRUITING)

Study contacts

• Study coordinator: Tommaso Sanna

Conditions: Pulmonary Edema Cardiac Cause