Comparison of PEEP in Acute Decompensated Heart Failure (NCT04853563) | Clinical Trial Compass
UnknownNot Applicable
Comparison of PEEP in Acute Decompensated Heart Failure
South Korea120 participantsStarted 2021-04-20
Plain-language summary
Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Subject who was diagnosed with congestive heart failure and objective evidence of pulmonary congestion (pulmonary edema on simple chest radiography or positive B-line on lung ultrasonography AND elevated B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide level) as a reason for invasive mechanical ventilation
✓. Age over 19 years old
✓. Subject who agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the clinical site.
Exclusion criteria
✕. Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
✕. Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
✕. Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score \>10
✕. Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
✕. Predominant right ventricular failure defined as following; clinical evidence of right ventricular failure by attending physician's discretion including hepatojugular reflux, Kussmaul sign, cardiac liver cirrhosis, hepato/splenomegaly, acites, thronmbocytopenia, etc.
✕. Subject who are not on mechanical ventilation before open heart surgery
✕. Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes
✕. Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction