Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.
Despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfunction continues to be one of the complications of the greatest concern in patients undergoing cardiac surgery with cardiopulmonary bypass. Brain injury can manifest itself through permanent or temporary injury, contributing to the increase in-hospital mortality, in the length of stay in intensive care, in the length of hospital stay, to a higher incidence of motor dysfunction requiring rehabilitation, and consequently, to reduced quality of life. Even though the causes of brain injury are multifactorial, perioperative cerebral hypoperfusion, tissue hypoxia, and thromboembolic events are among the main factors related to neurological dysfunction. Several clinical studies have indicated an association between cerebral desaturation and the increase of neurological complications. Cerebral oximetry monitoring using near-infrared spectroscopy (NIRS) is a non-invasive technique used to estimate regional cerebral oxygen saturation (rSO2) and has been associated with diminishing the incidence of neurological complications. There is no consensus in the literature about its real benefit, mainly due to the absence of well-designed scientific studies that demonstrate that cerebral desaturation associated with intervention measures to improve rSO2, are related to the prevention of neurological dysfunction in adult cardiac surgery. The study hypothesis evaluates whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with early interventions to optimize rSO2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
326
In the intervention group, an alarm threshold below 15% of the baseline rSO2 value will be established. Based on the predetermined algorithm the rSO2 will be maintained at or above 85% of the baseline measurements. If the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed to restore rSO2 to baseline levels.
Instituto Nacional de Cardiologia
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital São José
Criciúma, Santa Catarina, Brazil
Preoperative cognitive function
Mini Mental State Examination (MMSE)
Time frame: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery
Mini Mental State Examination (MMSE)
Time frame: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder
Mini Mental State Examination (MMSE)
Time frame: Post-surgery (90 days after surgery)
Preoperative cognitive function II
Montreal Cognitive Assessment (MoCA) test
Time frame: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery II
Montreal Cognitive Assessment (MoCA) test
Time frame: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder II
Montreal Cognitive Assessment (MoCA) test
Time frame: Post-surgery (90 days after surgery)
Preoperative cognitive function III
The Telephone Interview for Cognitive Status (TICS)
Time frame: Pre-surgery (within 10 days before)
Postoperative cognitive dysfunction - delayed cognitive recovery III
The Telephone Interview for Cognitive Status (TICS)
Time frame: Post-surgery (7 days after surgery)
Postoperative cognitive dysfunction - neurocognitive disorder III
The Telephone Interview for Cognitive Status (TICS)
Time frame: Post-surgery (90 days after surgery)
Incidence of postoperative delirium
Delirium will be assessed postoperatively for seven days or until discharge
Time frame: Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge
Neurological injury type I (stroke)
The incidence of neurological injury type I will be evaluated for 30 days
Time frame: Post-surgery (until 30 days after surgery)
Duration of mechanical ventilation
The duration of mechanical ventilation will be evaluated
Time frame: Post-surgery (until 30 days after surgery)
Length of stay at the intensive care unit (ICU)
The length of stay at the intensive care unit (ICU) will be evaluated
Time frame: Post-surgery (until 30 days after surgery)
Length of stay at the hospital
The length of stay at the hospital will be evaluated
Time frame: Post-surgery (until 30 days after surgery)
Incidence of mortality resulting from all causes
All causes of mortality will be assessed for 30 days
Time frame: Post-surgery (until 30 days after surgery)
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