HF vs NIV in Acute Cardiogenic Pulmonary Edema (HFvsNIV)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Pulmonary Edema Cardiac Cause

Treatments: Procedure: NPPV/HFNC; Procedure: HFNC/NPPV

Study type: Interventional

Funder types: Other

Identifiers

NCT05989139

5615

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

NPPV

Experimental group

Description:

non-invasive positive-pressure ventilation arm

Treatment:

Procedure: NPPV/HFNC

HFNC

Experimental group

Description:

High-flow nasal cannulae arm

Treatment:

Procedure: HFNC/NPPV