NCT04853563Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Ventilator-free day at 28-day
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Ventilator-free day at 28-day
时间窗: 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.
次要结局
未报告次要终点
研究者
Min-Seok Kim
professor of medicine
Asan Medical Center
研究点 (2)
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