The Value of Combined Critical Care Ultrasound and PAC Monitor Oriented Therapy Protocol (CUP Protocol) to Prevention and Treatment of Patients of ARDS(Acute Respiratory Distress Syndrome) With ACP(Acute Cor Pulmonate)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 主要终点
- 28-day mortality
研究概览
简要总结
We hypothesize that combined critical care ultrasound and PAC monitoring-oriented therapy protocol (CUP protocol), would improve prognosis of patients of ARDS with right ventricular dysfunction.
Therefore, the overall goal of the study is: 1) To build the combined critical care ultrasound and PAC monitoring-oriented therapy protocol (CUP Protocol)in detail for patients of ARDS with RV dysfunction. Advantage of CUP protocol is that it directly aims at key parameters that we need for the prevention and treatment of such patients; we could improve the mechanical ventilation protocol, unequal pulmonary lesions, hemodynamics management and reduce pulmonary artery pressure according to these parameters, so that to improve the prognosis of the patients.2) To verify the value of CUP Protocol in ARDS with ACP.
详细描述
ARDS is a hot topic due to its high morbidity and mortality. Severe ACP is independent predictor of mortality of ARDS and mortality of patients of ARDS with ACP is up to 48% to 60%. Therefore, prevention and treatment of ACP is key of improvement of mortality of ARDS patients. The occurrence of ACP is closely related to elevated RV afterload, which is due to pulmonary vascular spasm (caused by hypoxia and hypercapnia) and effect of cardiopulmonary interaction (due to inadequate mechanical ventilation), as well as the factors such as inadequate fluid treatment and other inadequate treatments. Therefore, ARDS with right ventricular dysfunction is hard to treat and easy to aggravate.
Critical care ultrasound could show pathophysiologic changes of lung and ventricular interaction and direct etiological treatment and pulmonary artery catheter could perform continuous and accurate monitoring. Therefore, Critical care ultrasound and PAC have their own advantages respectively and is complementary to each other theoretically. Experts opinions recommend echocardiography is mandatory and PAC could be considered in ventilated ARDS patients. However, there is no acknowledged therapeutic protocol, and no one know how to combine these two monitor tools, including specific application protocol, integration of parameters and the decision tree.
We had demonstrated the feasibility of combined monitoring protocol oriented delicate fluid management and mechanical ventilation, and the value of kidney protection under systemic treatment of optimized monitoring through the kidney contrast-enhanced ultrasonography. At the same time, we preliminary built the systemic diagnostic and treatment decision tree and provided the way and entry point of our study.
We hypothesize that combined critical care ultrasound and PAC monitoring-oriented therapy protocol (CUP protocol), would improve prognosis of patients of ARDS with right ventricular dysfunction.
Therefore, the overall goal of the study is: 1) To build the combined critical care ultrasound and PAC monitoring-oriented therapy protocol (CUP Protocol)in detail for patients of ARDS with RV dysfunction. Advantage of CUP protocol is that it directly aims at key parameters that we need for the prevention and treatment of such patients; we could improve the mechanical ventilation protocol, unequal pulmonary lesions, hemodynamics management and reduce pulmonary artery pressure according to these parameters, so that to improve the prognosis of the patients.2) To verify the value of CUP Protocol in ARDS with ACP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.age≥18year;
- •2.moderate to severe ARDS(A. Acute onset or aggravated respiratory symptoms within one week; B. Respiratory failure cannot be explained by cardiac dysfunction or fluid overload; C. Bilateral infiltrates cannot be completely explained by pleural effusion, nodules, masses, and collapse; D. When CPAP/PEEP>5cmH2O, 100mmHg<PaP2/FiO2<200mmHg, or CPAP/PEEP>5cmH2O, PaP2/FiO2<100mmHg.
- •3.Cardiac ultrasound indicates signs of right ventricular dysfunction (apical four-chamber view showed right ventricular end-diastolic area: left ventricular end-diastolic area ratio>0.6);
- •4.The informed consent were signed.
排除标准
- •Existing contraindications of PAC, such as right ventricular outflow obstruction, tricuspid valve stenosis, pulmonary artery stenosis, severe bleeding tendency;
- •complicated congenital heart disease;
- •pregnant;
- •patients treated with ECMO.
研究组 & 干预措施
control group
Patients in control group received usual care that was decided by attending.
study group
Patients in study group who had been placed the PAC were performed critical care ultrasound(CCUS) to monitor the pathophysiological changes of the lung and the hemodynamics immediately.
干预措施: PAC catheter and critical care ultrasound examination (Device)
结局指标
主要结局
28-day mortality
时间窗: 28 days after enrollment
28-day mortality after enrollment
次要结局
- the length of ICU stay(0-360 days)
研究者
Kang Yan
Director
West China Hospital
