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临床试验/NCT01424800
NCT01424800已完成不适用

Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Blood flow

研究概览

简要总结

This study emphasizes on the influence of changes in systemic flow and systemic mean arterial blood pressure (MAP) during cardiopulmonary bypass (CPB) on cerebral oxygenation assessed by near-infrared spectroscopy (NIRS). The aim of the study is to determine whether variations in systemic flow, in MAP, or in both variables at the same time have the greatest impact on the cerebral oxygen saturation.

详细描述

Cerebral autoregulation is defined as the whole of regulatory mechanisms that maintains a constant cerebral blood flow (CBF) during changes in cerebral perfusion pressure (CPP). Cerebrovascular resistance adjusts when CPP changes in order to keep CBF constant. In contrast with this concept of pressure-mediated autoregulation, it is suggested that cerebral autoregulation is focused on maintaining homeostasis of the cerebral metabolic rate of oxygen (CMRO2). We assume that both flow and pressure contribute to the regulation of CMRO2.

Assessment of cerebral oxygenation - Cerebral oxygen saturation will be monitored with near-infrared spectroscopy (NIRS). NIRS allows simple, continuous and non-invasive measurement of cerebral oxygen saturation (ScO2)and primarily cerebral venous saturation. Cerebral oxygen saturation will be monitored with a FDA-approved devices: INVOS 5100 (Somanetics Corporation, Troy, MI, USA).

To study the effects of changes in pressure and in flow, we need a condition where we can alter these variables separately and in a controlled manner. Therefore this study will be performed during cardiopulmonary bypass (CPB). Pressure will be varied with the administration of routinely used vasoactive substances, while flow will be varied by altering the pump flow manually. We hypothesize that if we change one parameter (pressure or flow), a compensatory mechanism will preserve the CMRO2 homeostasis, with no change in ScO2. On the other hand, if we change both pressure and flow, we expect a significant effect on cerebral oxygen saturation. With 20 % changes in pressure and/or flow, we expect a change in NIRS values of approximately 5 %. Previous studies showed that this kind of reduction is well tolerated by the brain. This means that the proposed changes are within the normal physiological range, and will have no adverse effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21-100 years, scheduled for elective cardiac surgery, written informed consent.

排除标准

  • History of cerebrovascular disease or symptomatic carotid artery stenosis.

结局指标

主要结局

Blood flow

时间窗: during the entire surgery

Changes in blood flow during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.

Blood pressure

时间窗: during the entire surgery

Changes in blood pressure during cerebral oxygen saturation measured with NIRS, during surgery when the patient is on cardiopulmonary bypass.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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