跳至主要内容
临床试验/NCT03827863
NCT03827863Unknown不适用

The Prospective Observational Study of ARDS Related Acute CorPulmonale and the Randomized Controlled Study of ARDS Aimed Circulation Protection China (ACPC)

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
28 days SURVIVAL

研究概览

简要总结

The investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies. The goals are the following.

First, morbidity and mortality rate of ARDS with ACP in the ICU across Chinese mainland.

Second, forming the diagnostic ultrasound strategy of ARDS-ACP, namely TRIP procedures. And predictive value of diagnostic strategy for ACP or prognosis of ACP were calculated.

Third, comparison of ventilator parameters for ACP and non-ACP or survivor and non-survisors, which reaveald that of inappropriate mechanical ventilation on circulation and prognosis. Screening for risk factors of ARDS with ACP.

详细描述

Acute respiratory distress syndrome (ARDS) is an acute and critical illness characterized by progressive dyspnea and refractory hypoxemia caused by intrapulmonary or extrapulmonary factors. The mortality rate of ARDS is extremely high. ACP caused by pulmonary circulatory disorder is its main clinical feature, which is related to the severity of lung injury in ARDS patients. It has been recognized that the ACP is an independent risk factor for the prognosis of patients with ARDS. Positive pressure mechanical ventilation is an important ARDS treatment strategy for ARDS. Especially the lung protective ventilation strategy with "small tidal volume and increased PEEP" as the core content, which achieved a milestone of lower the mortality of ARDS. However, improper use of positive pressure mechanical ventilation can increase right ventricular load and increase mortality in ARDS patients. Therefore, understanding the effect of positive pressure mechanical ventilation on right heart function in patients with ARDS is important for prevention and treatment for the ACP of ARDS and reduction of ARDS mortality.

The alveolar edema, alveolar collapse, and hypoxic pulmonary vasoconstriction loss caused by increased pulmonary vascular permeability and release of inflammatory mediators resulted in loss of ventilation/blood flow, severe hypoxemia, pulmonary vasospasm, pulmonary microthrombus formation, which increased pulmonary arterial pressure and even APC. Positive pressure mechanical ventilation maintains alveolar ventilation through positive airway pressure, prevents premature alveolar collapse by positive end expiratory pressure (PEEP), changes intrathoracic pressure and lung volume, and affects the right ventricle load. Different studies have found that the incidence of ACP in patients with ARDS is from 22% to 60%. Jardin, et al found that patients with ARDS had a significant increase in ACP and mortality when the airway pressure was greater than 26 cmH2O, which revealed that the difference in positive pressure mechanical ventilation settings has a significant difference in the right heart function of ARDS patients. Mekontso, et al propose a simple clinical risk score for early identification of ACP included pneumonia as cause of ARDS, driving pressure ≥18cmH2O, PaO2/FiO2 ratio<150 mmHg, and PaCO2≥48mmHg. However, for the morbidity and mortality of ACP in ARDS, the related risk factors and criteria are different due to the influence of the different etiology of ARDS and the different study time. For these reasons, the investigators established a national cohort of Chinese ARDS with Acute CorPulmonale to enable prospective observational studies.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18≤ aged ≤85 years old
  • received a diagnosis of ARDS with Acute CorPulmonal
  • provided signed informed consent

排除标准

  • are diagnosed as cardiogenic pulmonary edema
  • are diagnosed as Idiopathic pulmonary fibrosis acute exacerbation
  • are participating in other interventional clinical trials
  • refused to continue to participate in the study or refused further treatment
  • unable to complete the study procedure even if assisted and otherwise unable to comply with the study protocol

结局指标

主要结局

28 days SURVIVAL

时间窗: 28 days after ICU admission

length of stay of ICU

时间窗: 1 years

mechanical ventilation time

时间窗: 1 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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