NCT05989139Recruiting
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study's primary aim is * to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain. * to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed. * to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort). Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and echocardiographic evaluation
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jun 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- NCT number
- NCT05989139
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2024 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of fever in the previous 4 days;
- Previous cardiac surgery,
- Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.
Lab values
- White blood cell count \> 12.000;
- Increased procalcitonin serum levels;
Age
- Age \<18 y.o.;
Other
- Hypercapnia with respiratory acidosis (PaCO2 \> 45 mmHg with pH \< 7.35);
- Consolidative areas at chest radiograph;
- Hypotension (systolic blood pressure \< 85 mmHg);
- Cardiogenic shock;
- Right ventricular (RV) dysfunction;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Policlinico Agostino Gemelli Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.