跳至主要内容
临床试验/NCT06152744
NCT06152744招募中不适用

Evaluation of Membrane Lung Function for Patients Receiving Venovenous Extracorporeal Membrane Oxygenation in High-altitude Regions

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年12月5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
40
试验地点
1
主要终点
Initial assessment of membrane lung oxygen uptake

研究概览

简要总结

Over the last 20 years, extracorporeal membrane oxygenation (ECMO) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ECMO circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. The prolonged use of an ECMO circuit increases the risk of membrane lung (ML) dysfunction. The ML is responsible for taking in oxygen and removing carbon dioxide. The non-biologic surface of the ML triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ML dysfunction. Coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. Moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. These three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ML exchanges. Worsening oxygenation during ECMO should prompt quantification of oxygen transfer. ML exchange is indicated when the ML can no longer meet the patient's oxygen demand. The partial pressure of Post-ML arterial oxygen less than 200 mmHg is the most important consideration in this decision. In some high-altitude regions of China, ECMO treatment is also routinely conducted. The experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. This study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.

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

入选标准

  • Receiving ECMO support

排除标准

  • Unable to obtain post-membrane blood gas
  • Pregnancy
  • Patients cannot receive anticoagulation
  • Refusal to participate in the trial

结局指标

主要结局

Initial assessment of membrane lung oxygen uptake

时间窗: On the third day of ECMO support

O2 content of post-ML blood - O2 content of pre-ML blood

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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