RecruitingNot ApplicableNCT05989139

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

30 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Edema Cardiac Cause

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two breathing support methods — high-flow nasal oxygen therapy (HF) versus non-invasive ventilation (NIV, such as a CPAP-like mask) — for people arriving at the emergency room or ICU with acute cardiogenic pulmonary edema, which is when the heart suddenly fails and fluid fills the lungs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with acute cardiogenic pulmonary edema (acute heart failure causing fluid in the lungs) - The condition is caused by a heart attack, acute valve disease, heart muscle inflammation, or pre-existing heart failure **You may NOT be eligible if...** - Your breathing problems have a different cause (not heart failure) - You need immediate intubation (a breathing tube) - You have other severe health conditions that prevent study participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENPPV/HFNC

Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. NPPV will be delivered through a full-face mask with a FiO2 starting at 100% and then titrated to achieve an SpO2 of 92-98%. Expiratory positive airway pressure (PEEP) will be firstly set to 5 cmH2O and then increased to a maximum of 15 cmH2O based on SpO2. Pressure support (PS) will be set to an initial value of 10 cmH2O and then increased if signs of respiratory distress persisted or worsened to a maximum value of 20 cmH2O. After 40 minutes, patient is shifted to HFNC ventilation support for 40 minutes. At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

PROCEDUREHFNC/NPPV

Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. HFNC oxygen therapy will start at a flow rate of 60 L/min and will be gradually decreased by 5 cmH2O at time if the patient experienced discomfort. FiO2 will be started at 100% and then titrated to maintain a peripheral oxygen saturation of 92%-98%. Active heating and humidification were provided using MR850, Fisher and Paykel, with a temperature chamber of 37°C. After 40 minutes, patient is shifted to NPPV ventilation support for 40 minutes At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

Locations(1)

Fondazione IRCCS Policlinico Agostino Gemelli Roma

Roma, Italy

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NCT05989139