Myocardial Infarction Clinical Trial
Official title:
Cerebral Oximetry and Perioperative Outcome in Non-Cardiac Surgery
Cerebral desaturations occur frequently in patients undergoing non-cardiac surgery. The
definition of what constitutes a cerebral desaturation, the incidence of the phenomenon, the
association between desaturations and perioperative outcome, and the mechanistic
explanations of cerebral desaturations remain unexamined. This study seeks to identify the
true incidence and magnitude of cerebral desaturations in high-risk non-cardiac surgical
patients and the association between desaturations and perioperative outcome.
The investigators will attempt to determine the following (1) The proper definition,
incidence and severity of decreased cerebral saturation (rSO2) in high-risk non-cardiac
surgical patients (2) the mechanisms surrounding decreases in rSO2 by correlating it with
alterations in physiologic parameters (such as blood pressure, cardiac output, hemoglobin
concentration, and carbon dioxide levels) and (3) to correlate the incidence and severity of
decreased rSO2 with relevant perioperative.
The investigators will also analyze a panel of inflammatory biomarkers to determine if these
biomarkers have the ability to predict postoperative complications.
The investigators will study 200 high-risk patients undergoing high-risk non-cardiac
surgery. The investigators will determine the incidence and severity of decreases in rSO2,
the associated factors with the occurrence of decreased rSO2, and the relationship between
decreases in rSO2 and adverse perioperative outcome with a composite of well defined
perioperative complications such as death, myocardial infarction, cerebrovascular accident,
acute kidney injury, delirium, postoperative infections, and the need for mechanical
ventilation.
There have been a number of studies that have examined a link between intraoperative
decreases in rSO2 and adverse perioperative outcome3-7. These studies, the vast majority of
which have been in the setting of cardiac surgery, suggest that decreases in rSO2 (as
detected by near-infrared spectroscopy) may be related to both adverse neurologic and
non-neurologic sequelae. Interestingly, and importantly, the studies examining cerebral
desaturation in non-cardiac surgical patients (such as those undergoing major abdominal
surgery, carotid endarterectomy, liver transplantation, and pulmonary resection) have also
uncovered a link between cerebral desaturation and non-neurologic outcomes3,7-12. These
small studies have reported preliminary correlates between decreases in rSO2 and various
postoperative complications and prolonged length of stay. These studies have also shown that
the changes in rSO2 are not correlated with changes in traditional hemodynamic parameters
(mean arterial pressure (MAP) and heart rate).
All of these studies suffer from similar flaws, however. They are typically small in size,
have varying definitions of what constitutes a cerebral desaturation event, and have
incompletely, or poorly defined complications. Also lacking is a mechanistic explanation for
the cerebral desaturations as peripheral oxygen saturation typically remains near normal.
As a result, two natural questions arise in relation to this prior research. First, are
these cerebral desaturations causative of the adverse outcomes (including non-neurologic
complications), and second if these desaturations were treated (i.e. if cerebral oxygenation
was normalized) would outcome be improved (i.e. or are cerebral desaturations merely an
epiphenomenon)? Numerous studies have demonstrated the poor correlation of traditional
hemodynamic parameters (such as blood pressure and heart rate) to cardiac output and oxygen
delivery13-17. Historically in the fields of anesthesiology and critical care, we have
focused our monitoring and resuscitation targets on perfusion pressures rather than organ
flows. Neglecting the fact that organs require flow as well as pressure has led to an
over-reliance on normal vascular pressures (such as arterial, central venous, and pulmonary
capillary wedge pressures) as a surrogate for adequate organ flow18.
It is entirely possible that monitoring cerebral oxygenation and discovering a link between
desaturation and non-neurologic outcomes may show that the brain is an index organ for
tissue perfusion monitoring. That is to say, since the perfusion of major organs are
typically not monitored during anesthesia, cerebral oximetry is an excellent means to
monitor global decreases in tissue oxygen delivery. Consistent with this hypothesis, in the
largest cerebral oximetry trial to date, Murkin and colleagues discovered that the incidence
and magnitude of cerebral desaturations was related to major non-neurologic organ
morbidity19.
The investigators will also be collecting blood samples preoperatively and at 24 hours
postoperatively to determine if a panel of inflammatory biomarkers has the ability to
predict postoperative complications.
Primary Objective: to determine the incidence and severity of cerebral desaturation in
high-risk patients undergoing major vascular and abdominal surgery
Secondary Objectives:
1. To determine the factors associated with the occurrence of cerebral desaturation
2. To determine the relationship between desaturation and adverse perioperative outcome
3. To determine if the levels of a panel of inflammatory biomarkers is related to cerebral
desaturation and postoperative complications.
Study design: prospective observational study Population: 200 consecutive high-risk patients
undergoing non-cardiac surgery. High-risk patients will be defined as age> 65 undergoing
major non-cardiac surgery including abdominal aortic aneurysm repair, major hepatic
resection, colonic resection, pancreatoduodenectomy, or esophagectomy.
Methods: In addition to standard CAS monitors, all patients will undergo pulse contour
cardiac output monitoring and cerebral oxygen saturation monitoring. The anesthetic
technique will be at the discretion of the attending anesthesiologist. During the procedure,
the attending anesthesiologist will be blinded to the rSO2 data.
As with previous studies conducted at our institution, cardiorespiratory variables (such as
heart rate, systolic, diastolic and mean arterial blood pressures, peripheral and cerebral
oxygen saturation, end tidal CO2 tension, end tidal anesthetic gas concentration, and
cardiac index) will be sampled at a frequency of 60Hz. Data will be acquired from the
Philips Intellivue® Monitor (Philips Healthcare, Andover, MA), FloTrac/Vigileo® minimally
invasive CO monitor (Edwards Lifesciences, Orange County, CA), and the ForeSight® Cerebral
Oximiter (CasMED, Brantford CT) and processed with TrendFace Solo® software (IExcellence
Software, Germany). Arterial blood gas sampling will occur every 20 minutes. Other
intraoperative variables collected will include case duration, blood loss, total narcotic
dose, total benzodiazepine dose, use and dose of vasopressors, and use of neuraxial local
anesthetics.
The definition of a cerebral desaturation differs between previously performed studies. Some
have used an absolute decrease below 55%, variably defined decreases from the patients
'baseline' (either breathing room air or 100% oxygen), the time below a specific cerebral
saturation threshold, or area under a specific cerebral saturation threshold (this
measurement takes into account the duration and magnitude of a desaturation)3,5,21,22. Based
on the intraoperative data collected, The investigators will examine all of the currently
utilized definitions of cerebral desaturation and then construct receiver operating
characteristic curves to determine which parameter has then highest predictive ability to
link cerebral desaturation with perioperative outcome.
In consultation with our Biostatistical Consulting Unit the investigators calculated our
sample size using previously reported incidences of cerebral desaturation, which range from
15-26% and accepted a margin of error of 5%. Based on a conservative estimate of the
incidence (15%), The investigators would need a total of 195 patients to determine the
incidence of cerebral desaturations with a 5% margin of error (see figure 1). The
investigators will include 5 additional patients in our study due to our previous experience
of a 1% rate of data loss during acquisition of rSO2 data (related to technical failures).
The Lan and DeMets alpha spending function will be utilized to determine if the trial can be
stopped early.
As secondary outcomes, the investigators will attempt to correlate decreases in rSO2 with a
composite of well defined perioperative complications such as death, myocardial infarction,
cerebrovascular accident, acute kidney injury (defined by the AKIN criteria, table 223),
delirium (as defined by the CAM-ICU method, figure 324), postoperative infections, and the
need for mechanical ventilation >24 hours in the first 28 postoperative days.
Based on the results of this study the investigators will be able to determine, with the aid
of multivariate logistical regression analysis and the calculation of odds ratios, which
definition of cerebral desaturation is mostly closely linked with the aforementioned outcome
measures.
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