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临床试验/NCT06062212
NCT06062212招募中不适用

Effect of Transpulmonary Mechanical Power on the Prognosis of Patients With Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Patients successfully weaned from VV-ECMO

研究概览

简要总结

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO.

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

入选标准

  • Meet the diagnostic criteria of Berlin's definition for ARDS;
  • Receiving VV-ECMO support.

排除标准

  • Patients had been on high pressure (Ppeak >35 cm H2O) and a high fraction of inspired oxygen (FiO2>0.8) ventilation for >7 days;
  • Patients had a contraindication to heparinization;
  • Patients had an irreversible neurological injury;
  • Patients had severe chronic lung disease with life expectancy <6 months.

结局指标

主要结局

Patients successfully weaned from VV-ECMO

时间窗: After patients enrolled 60 days

Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

次要结局

  • 60-day mortality(After patients enrolled 60 days)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rui Wang

Principal Investigator

Beijing Chao Yang Hospital

研究点 (1)

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