Status:
UNKNOWN
Comparison of PEEP in Acute Decompensated Heart Failure
Lead Sponsor:
Asan Medical Center
Conditions:
Heart Decompensation
Mechanical Ventilation Pressure High
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 com...
Eligibility Criteria
Inclusion
- 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
- 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
- Subject with intracranial hemorrahge or ischemic stroke at the time of randomization
- Subject with irreversible neurologic damage or irreversible hepatic failure
- Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation
- Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)
- Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency
- Pregnant and/or lactating women
- Subject with life expectancy less than a year
- Subject who is not suitable to enrollment by investigator's discretion
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04853563
Start Date
April 20 2021
End Date
April 30 2024
Last Update
February 23 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505