NCT05989139 HF vs NIV in Acute Cardiogenic Pulmonary Edema
| NCT ID | NCT05989139 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Pulmonary Edema Cardiac Cause |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05989139 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Edema Cardiac Cause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05989139 currently recruiting?
Yes, NCT05989139 is actively recruiting participants. Contact the research team at Tommaso.sanna@policlinicogemelli.it for enrollment information.
Where is the NCT05989139 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05989139 clinical trial?
NCT05989139 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 30 participants.