Comparison of High VErsus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure (HELP-AFH) : Open-label Randomized Controlled Multi-center Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Asan Medical Center
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Ventilator-free day at 28-day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Low PEEP
Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 5 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. In this arm, the PEEP level is adjusted to 1 centimetre of water lower to a minimum PEEP level of 3 with every 30 minutes while maintaining a partial pressure of arterial blood oxygen above 65 millimeter of mercury or oxygen saturation >92% with pulse oxymetry.
Intervention: PEEP (Other)
High PEEP
Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 8 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. Thereafter, the PEEP level is adjusted to 1 centimetre of water higher to a minimum PEEP level of 10 with every 30 minutes.
Intervention: PEEP (Other)
Outcomes
Primary Outcomes
Ventilator-free day at 28-day
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Min-Seok Kim
professor of medicine
Asan Medical Center