Heart Decompensation, Mechanical Ventilation Pressure High
Conditions
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 compare clinical outcome according to low versus high PEEP.
Interventions
OTHERPEEP
High PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Age over 19 years old 3. 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
1. Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization 2. Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure 3. Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score \>10 4. Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction) 5. 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. 6. Subject who are not on mechanical ventilation before open heart surgery 7. Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes 8. Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction 9. Subject with intracranial hemorrahge or ischemic stroke at the time of randomization 10. Subject with irreversible neurologic damage or irreversible hepatic failure 11. Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation 12. Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease) 13. Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency 14. Pregnant and/or lactating women 15. Subject with life expectancy less than a year 16. Subject who is not suitable to enrollment by investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-free day at 28-day | up to 28-day | Starting at the day of randomization, and the days on non-invasive ventilation do not count. Successful extubation is defined as at least 24 hours wihtout reintubation independent of invasive assisted ventilation in survivor. Non-survivor within 28 days: ventilator-free day counted as 0, ventilator-free day among only survivor at 28-day will be counted for primary endpoint. |
Countries
South Korea
Contacts
Primary ContactMinseok Kim
Outcome results
None listed