Status:
RECRUITING
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Pulmonary Edema Cardiac Cause
Eligibility:
All Genders
18+ years
Phase:
NA
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 cardio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05989139
Start Date
January 1 2024
End Date
April 1 2027
Last Update
August 15 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico Agostino Gemelli Roma
Roma, Italy, 00168