Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiac Disease
- Cognitive Dysfunction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be monitored with cerebral oximetry using INVOS 5100 monitor (Covidien, Boulder, CO), with electrodes applied bilaterally in the frontal region. Following the placement of the electrodes, the baseline records HR, blood pressure, rSO2, and peripheral O2 saturation (SPO2) will be recorded following 1 minute of electrode placement and the proper verification of the signal on the monitor. Later, during the surgery, 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 in the intervention group to return the oximeter to baseline values. The alarm on the equipment should be programmed to signal values below 15% of the baseline values.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Patients will be masked concerning the allocation group. The anesthesiologist responsible for conducting the case will not be involved in the application of the neurocognitive tests, nor will he be aware of the test results. Investigators who apply the tests will be covered up by the patient allocation group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
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 s...
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.
Tracking Information
- NCT #
- NCT04766554
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Carlos Galhardo, MD Instituto Nacional de Cardiologia
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