Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
- Conditions
- Cognitive DysfunctionCardiac Disease
- Registration Number
- NCT04766554
- Lead Sponsor
- Instituto Nacional de Cardiologia de Laranjeiras
- Brief Summary
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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 326
- Age 60 or older
- Elective coronary artery bypass graft surgery using cardiopulmonary bypass
- Preoperative cognitive assessment by means of Mini-Mental State Examination (MMSE) test, greater than or equal to 24
- Signed informed consent
- Patients with focal neurologic deficit
- Carotid artery stenosis greater than 70%
- Patients with pre-existing cognitive dysfunction
- Patients with psychotic disorders
- History of allergy to adhesive part of the electrode
- History of craniofacial surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Preoperative cognitive function III Pre-surgery (within 10 days before) The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - neurocognitive disorder III Post-surgery (90 days after surgery) The Telephone Interview for Cognitive Status (TICS)
Postoperative cognitive dysfunction - neurocognitive disorder Post-surgery (90 days after surgery) Mini Mental State Examination (MMSE)
Preoperative cognitive function II Pre-surgery (within 10 days before) Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function Pre-surgery (within 10 days before) Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - delayed cognitive recovery II Post-surgery (7 days after surgery) Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery Post-surgery (7 days after surgery) Mini Mental State Examination (MMSE)
Postoperative cognitive dysfunction - neurocognitive disorder II Post-surgery (90 days after surgery) Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery III Post-surgery (7 days after surgery) The Telephone Interview for Cognitive Status (TICS)
- Secondary Outcome Measures
Name Time Method Length of stay at the intensive care unit (ICU) Post-surgery (until 30 days after surgery) The length of stay at the intensive care unit (ICU) will be evaluated
Neurological injury type I (stroke) Post-surgery (until 30 days after surgery) The incidence of neurological injury type I will be evaluated for 30 days
Duration of mechanical ventilation Post-surgery (until 30 days after surgery) The duration of mechanical ventilation will be evaluated
Length of stay at the hospital Post-surgery (until 30 days after surgery) The length of stay at the hospital will be evaluated
Incidence of mortality resulting from all causes Post-surgery (until 30 days after surgery) All causes of mortality will be assessed for 30 days
Incidence of postoperative delirium Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge Delirium will be assessed postoperatively for seven days or until discharge
Trial Locations
- Locations (2)
Instituto Nacional de Cardiologia
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital São José
🇧🇷Criciúma, SC, Brazil
Instituto Nacional de Cardiologia🇧🇷Rio de Janeiro, RJ, BrazilCarlos Galhardo, MDContact