跳至主要内容
临床试验/NCT04710173
NCT04710173已完成不适用

Establishment of a Early Risk Model of Extracorporeal Membrane Oxygenation(ECMO) in Children With Acute Respiratory Distress Syndrome (ARDS) in China

Children's Hospital of Fudan University3 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
3
主要终点
Survival rate

研究概览

简要总结

The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment

详细描述

Severe acute respiratory distress syndrome (ARDS), especially those caused by severe viral pneumonia, is still an important factor in the death of children, with a case fatality rate of 55%. The treatment includes lung protective ventilation and advanced ventilation support, but the effect is still not ideal for severe patients. ECMO can effectively support the respiratory system and provide good oxygen exchange. However, the survival rate of ECMO treatment in children with ARDS has a large bias.One of the key factors is the uneven timing of ECMO activation, which significantly affects the prognosis.This study intends to design a multi-center, prospective, non-randomized controlled trial , through retrospective research to find relevant factors affecting the prognosis of ECMO treatment, and to screen key indicators related to the timing of intervention; through a prospective cohort study to screen Good indicators and cut-off values suitable for starting ECMO , constructing and verifying comprehensive prediction models.

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
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Acute onset; within 7 days of clinical insult
  • Chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease
  • Edema not fully explained by fluid overload or cardiac failure
  • May present as new acute lung disease in setting of chronic lung disease and/or heart disease
  • Viral etiology is clear

排除标准

  • Perinatal lung disease
  • Large intracranial bleed with mass effect or need for neurosurgical intervention
  • Hypoxic cardiac arrest without adequate CPR
  • Irreversible underlying cardiac or lung pathology (and not a transplant candidate)
  • Pulmonary hypertension and chronic lung disease
  • Chronic multiorgan dysfunction
  • Incurable malignancy
  • Allogenic bone marrow recipients with pulmonary infiltrates
  • Hepatic or renal failure
  • Pertussis infection in infants
  • Fungal pneumonia
  • Immunodeficiency

结局指标

主要结局

Survival rate

时间窗: 28 days after hospital discharge

The survival rate of children in 28 days after hospital discharge

次要结局

  • ECMO weaning rate(48 hours after ECMO weaning)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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