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临床试验/NCT05669183
NCT05669183招募中不适用

Comparison of Peripheral and Central Intubation on Hemodynamics in Veno-arterial-extracorporeal Membrane Oxygenation (RECOVERY): a National, Multi-center, Prospective, Cohort Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2023年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
136
试验地点
1
主要终点
Left ventricular end-diastolic volume (ml)

研究概览

简要总结

The goal of this clinical trial is to monitor hemodynamic differences between central veno-arterial extracorporeal membrane oxygenation (VA ECMO) and peripheral VA ECMO. The main question it aims to answer is:

  • Efficacy of the different cannulation strategies for the establishment of for VA-ECMO circulation on hemodynamics and organ perfusion.

Participants require VA ECMO support, will be divided into two groups in an intention-to-treat analysis: central artery cannulation and peripheral artery cannulation.

Researchers will analyze different cannulation strategies for VA-ECMO and identify potential advantages and disadvantages for two groups of VA-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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age≥18 years
  • Participants with cardiogenic shock
  • Obtaining informed consent from participants or their affiliated beneficiaries

排除标准

  • Irreversible heart failure
  • Contraindications to anticoagulation therapy
  • Uncontrolled bleeding
  • Irreversible neurological pathology
  • Participants limited to extracorporeal cardiopulmonary resuscitation

结局指标

主要结局

Left ventricular end-diastolic volume (ml)

时间窗: Through VA ECMO support completion, an average of 1 week

echocardiography

Mitral valve area(cm2)

时间窗: Through VA ECMO support completion, an average of 1 week

echocardiography

Oxygen saturation-no. (%)

时间窗: Through VA ECMO support completion, an average of 1 week

Blood gas analysis

Left ventricular End-systolic volume (ml)

时间窗: Through VA ECMO support completion, an average of 1 week

echocardiography

Stroke volume (ml)

时间窗: Through VA ECMO support completion, an average of 1 week

echocardiography

次要结局

  • Duration of ICU stay(Through study completion, up to 2 years)
  • Duration of hospital stay(Through study completion, up to 2 years)
  • VA ECMO duration(Through VA ECMO support, an average of 1 week)
  • Cannulation-related complications(Through study completion, up to 2 years)
  • Rate of successful weaning from VA ECMO(Through study completion, up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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