Cerebral Oxygen Saturation Clinical Trial
Official title:
Influence of Variations in Systemic Blood Flow and Blood Pressure on Cerebral Oxygenation Measured by Cerebral Oximetry
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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