Cardiac Performance in Mechanically Ventilated Patients With Severe Pneumonia by SARS-CoV-2: Echo-COVID Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of patients with left ventricle dysfunction (hypokinetic)
研究概览
简要总结
Although COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.
详细描述
The objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.
Material and Methods This prospective, multicenter study was conducted between April and June 2020 in the intensive care unit (ICU) of four university-affiliated hospitals of Santiago, Chile. Local ethics committee of each center approved the study and waived the need to provide written informed consent (protocol ID: 200422002). All participating centers have expertise in CCE on clinical grounds.
The study population Were included systematically all consecutive patients with severe SARS-CoV-2 pneumonia, defined as respiratory failure requiring invasive mechanical ventilation (MV). Patients were included within the first 24 hours of MV. COVID-19 was confirmed by a positive polymerase chain reaction test. The main exclusion criteria were age under 18 years old, severe valvulopathy, poor ultrasound window and do-not-resuscitate status.
Demographic data, Acute Physiology and Chronic Health Evaluation II (APACHE), Sequential Organ Failure Assessment (SOFA) and respiratory system mechanics were recorded.
Echocardiography Transthoracic echocardiography was performed by intensivists trained in echocardiography in according to CCE. Echocardiographic measurements were obtained with a Vivid i echocardiography system (GE Medical Systems, Milwaukee, WI, USA), Philips CX 50 (Philips Healthcare, DA Best, The Netherlands), and Mindray M9 (Bio-Medical Electronics Co., Shenzhen, Chine), as used in each center. All patients were adapted to MV on continuous IV sedation during the echocardiographic assessment. Measurements were acquired at end-expiration and averaged over three consecutive cardiac cycles in according to current recommendations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Covid-19 confirmed by a positive polymerase chain reaction test
- •Mechanical ventilation
排除标准
- •Up to 24 hours on mechanical ventilation
- •Severe valvulopathy
- •Poor ultrasound window
- •Do-not-resuscitate status
结局指标
主要结局
Percentage of patients with left ventricle dysfunction (hypokinetic)
时间窗: 3 month
Hypokinetic left ventricle function (left ventricle ejection fraction \<45%)
Percentage of patients with acute cor pulmonale
时间窗: 3 month
Acute cor pulmonale was defined as a dilated right ventricle (right ventricle end-diastolic area/left ventricle end-diastolic area ratio \>0.6) associated with the presence of paradoxical septum motion
次要结局
- Differences in respiratory system compliance between patients with and without acute cor pulmonale(Within the first 24 hours of mechanical ventilation.)
- Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale(Within the first 24 hours of mechanical ventilation.)
- Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale(Within the first 24 hours of mechanical ventilation.)
研究者
Emilio Valenzuela
M.D. Intensivist
Pontificia Universidad Catolica de Chile