A Pilot Study of the Relationship Between Oxygen Delivery and Consumption During Extracorporeal Membrane Oxygenation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Oxygen consumption (VO2)
研究概览
简要总结
The investigators propose to examine the relationship between DO2 and VO2 in critically ill patients requiring an Extracorporeal Membrane Oxygenation (ECMO) machine. This machine can provide complete support of heart and lung function. In so doing, the investigators will be able to avoid physiologic coupling by increasing DO2 mechanically, by increasing blood flow through the ECMO circuit.
Null Hypothesis:
Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is not associated with an increase in oxygen consumption.
Alternate Hypothesis:
Increased oxygen delivery, by means of an increased rate of extracorporeal blood flow, is associated with an increase in oxygen consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the Critical Care Unit on veno-arterial ECMO.
- •Hemodynamic stability established, as adjudged by the treating CCU staff physician.
- •Informed consent by parent or legal guardian.
- •Approval by treating CCU staff physician to approach parents/guardians for consent process at any given time.
排除标准
- •Patients in the Critical Care Unit on veno-venous (VV) ECMO.
- •Inability to tolerate study period without red cell transfusion.
- •Presence of a large leak around the endotracheal tube (> 10% tidal volume).
- •Patients requiring > 70 % FiO2 at the time of potential enrollment.
- •Parent or legal guardian refuse consent.
研究组 & 干预措施
Patients on veno-arterial (VA) ECMO
干预措施: Extracorporeal blood flow via ECMO machine (Device)
结局指标
主要结局
Oxygen consumption (VO2)
时间窗: 90min
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
时间窗: Baseline
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
时间窗: 30min
VO2 will be measured using a mass spectrometer as this is the gold standard.
Oxygen consumption (VO2)
时间窗: 60min
VO2 will be measured using a mass spectrometer as this is the gold standard.
次要结局
- Arterial serum lactate level(Baseline, 30min, 60min, 90min)
- Oxygen extraction ratio.(Baseline, 30min, 60min, 90min)