跳至主要内容
临床试验/NCT07526181
NCT07526181尚未招募不适用

Cerebral Oximetry in Relation to Pulmonary Artery Catheter Parameters and Extracorporeal Membrane Oxygenation Flow in Patients Supported With Veno-arterial ECMO

Assiut University0 个研究点目标入组 30 人开始时间: 2026年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation

研究概览

简要总结

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

  1. Cerebral Oximetry
  2. ECMO Parameters ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration
  3. Pulmonary Artery Catheter Data and hemodynamics:

Cardiac output / cardiac index, SvO₂, Central venous pressure (CVP). 4. other variables: P/F ratio, MAP, Heart rate, Arterial blood gases, hemoglobin, Lactate, Vasopressor / inotrope doses and Sedation score (RASS). 5. Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening. 6. Follow-up data:

  • ECMO duration.
  • Need for oxygen therapy/mechanical ventilation.
  • ICU survival.

详细描述

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

  1. Cerebral Oximetry

Bilateral frontal sensors, rScO₂ recorded:

at baseline (within 1 hour of ECMO initiation) then every 12 hours. 2. ECMO Parameters Pump speed (RPM) ECMO blood flow (L/min) every 12 hours. Sweep gas flow Cannulation configuration Arterial cannulation site 3. Pulmonary Artery Catheter Data and hemodynamics:

Cardiac output / cardiac index every 12 hours. SvO₂. Central venous pressure (CVP) Mean pulmonary artery pressure. Pulmonary capillary wedge pressure. Systemic vascular resistance. 4. Echocardiography parameters: recorded every 12 hours. LV ejection fraction. LVOT VTi. LVED dimension. Aortic valve opening. 5. Other variables:

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

入选标准

  • Age ≥ 18 years
  • Patients supported with veno-arterial ECMO.
  • Presence of a pulmonary artery catheter.
  • Expected ECMO support ≥ 24 hours.
  • Patient with good echocardiographic window.

排除标准

  • Pre-existing severe neurological injury (e.g. massive stroke, traumatic brain injury).
  • Intracranial pathology affecting NIRS reliability.
  • Facial or scalp conditions preventing NIRS probe placement.
  • ECMO duration < 48 hours.
  • Poor echocardiographic window.

结局指标

主要结局

correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation

时间窗: from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa Roshdy Abdul Satar Mohamed

Assistant lecturer

Assiut University

相似试验