Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Effect of Regional Cerebral Oxygen Saturation Monitoring On Neurological Outcome In Patients Undergoing Aortic Arch Surgery
The investigators hypothesize that early intervention to optimize regional cerebral oxygenation detected by cerebral oximetry monitoring during deep hypothermic circulatory arrest (DHCA) for patients undergoing aortic surgery will decrease the incidence of transient and permanent neurological dysfunction and improve neurocognitive impairment.
Permanent or transient neurologic dysfunction is a frequent complication in patients
undergoing aortic arch surgery.
Two basic methods of brain protection are currently used concomitantly with these complex
surgical procedures: deep hypothermic circulatory arrest (DHCA) with or without retrograde
cerebral perfusion (RCP)and selective antegrade hypothermic cerebral perfusion. Hypothermic
circulatory arrest provides an optimal bloodless operative field, but the incidence of
neurological dysfunction increases when the duration of DHCA exceeds 45-50 minutes.
Antegrade cerebral perfusion is accomplished by means of direct differential cannulation of
the common carotid and right subclavian arteries. Because this technique of brain protection
requires a separate perfusion circuit, vigilant monitoring of perfusion pressure and flow
rate is of utmost importance. Multiple studies have demonstrated that antegrade selective
cerebral perfusion is a well established technique used for cerebral protection during
aortic surgery requiring longer periods of DHCA with favorable results in hospital mortality
and neurologic outcome. The permanent neurological dysfunction was noted to be 3.8% and the
transient neurologic dysfunction to be 7.1% for patients that received antegrade selective
cerebral perfusion.
Similarly, neurocognitive studies of DHCA with antegrade cerebral perfusion for patients
undergoing aortic arch operations demonstrated 9 % transient neurocognitive impairment for 2
days postoperatively that lasted up to 3 weeks thereafter. Consistent with current surgical
practice, the University of Michigan uses antegrade selective cerebral perfusion for all
patients undergoing aortic arch surgery requiring DHCA with or without RCP.
A number of monitoring modalities have been used for detecting cerebral malperfusion during
aortic surgery or carotid surgery, including transcranial Doppler ultrasound and near
infrared spectroscopy (NIRS).
The impact of these monitoring modalities on clinical (neurologic) outcome has not been
clearly established. Currently, NIRS has gained considerable attention and acceptance as a
non-invasive monitor of cerebral oxygenation. One study showed that a sustained drop in the
regional oxygen saturation (rSO2) below 55% for over 5 minutes using cerebral oximetry is
closely related to the occurrence of neurological events following aortic surgery. Another
study strongly supported that rSO2 should not drop > 20% from baseline to prevent neurologic
compromise. In a cohort of elective coronary artery bypass graph (CABG) patients,
intervention for cerebral desaturations did show significantly less major organ morbidity or
mortality (death, ventilation > 48 h, stroke, myocardial infarction, return for
re-exploration. Whether NIRS can be used as a monitor to provide rapid detection and
prevention of cerebral ischemia by early intervention that may improve neurological outcome
in patients undergoing aortic surgery requiring DHCA with or without RCP is currently
unknown.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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