Clinical trial NCT04766554: Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Cognitive Dysfunction
Keywords: Intraoperative Neurophysiologic Monitorings
Lead sponsor: Instituto Nacional de Cardiologia de Laranjeiras
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 326
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Preoperative cognitive function
timeFrame: Pre-surgery (within 10 days before)
measure: Postoperative cognitive dysfunction - delayed cognitive recovery
timeFrame: Post-surgery (7 days after surgery)
measure: Postoperative cognitive dysfunction - neurocognitive disorder
timeFrame: Post-surgery (90 days after surgery)
measure: Preoperative cognitive function II
timeFrame: Pre-surgery (within 10 days before)
measure: Postoperative cognitive dysfunction - delayed cognitive recovery II
timeFrame: Post-surgery (7 days after surgery)
measure: Postoperative cognitive dysfunction - neurocognitive disorder II
timeFrame: Post-surgery (90 days after surgery)
measure: Preoperative cognitive function III
timeFrame: Pre-surgery (within 10 days before)
measure: Postoperative cognitive dysfunction - delayed cognitive recovery III
timeFrame: Post-surgery (7 days after surgery)
measure: Postoperative cognitive dysfunction - neurocognitive disorder III
timeFrame: Post-surgery (90 days after surgery)
Secondary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively twice a day during the first seven days or until discharge
measure: Neurological injury type I (stroke)
timeFrame: Post-surgery (until 30 days after surgery)
measure: Duration of mechanical ventilation
timeFrame: Post-surgery (until 30 days after surgery)
measure: Length of stay at the intensive care unit (ICU)
timeFrame: Post-surgery (until 30 days after surgery)
measure: Length of stay at the hospital
timeFrame: Post-surgery (until 30 days after surgery)
measure: Incidence of mortality resulting from all causes
timeFrame: Post-surgery (until 30 days after surgery)
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
state: RJ
city: Criciúma
country: Brazil
facility: Hospital São José
state: SC
Study officials:
affiliation: Instituto Nacional de Cardiologia
name: Carlos Galhardo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng F, Sheinberg R, Yee MS, Ono M, Zheng Y, Hogue CW. Cerebral near-infrared spectroscopy monitoring and neurologic outcomes in adult cardiac surgery patients: a systematic review. Anesth Analg. 2013 Mar;116(3):663-76. doi: 10.1213/ANE.0b013e318277a255. Epub 2012 Dec 24.
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citation: Slater JP, Guarino T, Stack J, Vinod K, Bustami RT, Brown JM 3rd, Rodriguez AL, Magovern CJ, Zaubler T, Freundlich K, Parr GV. Cerebral oxygen desaturation predicts cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg. 2009 Jan;87(1):36-44; discussion 44-5. doi: 10.1016/j.athoracsur.2008.08.070.
citation: Lei L, Katznelson R, Fedorko L, Carroll J, Poonawala H, Machina M, Styra R, Rao V, Djaiani G. Cerebral oximetry and postoperative delirium after cardiac surgery: a randomised, controlled trial. Anaesthesia. 2017 Dec;72(12):1456-1466. doi: 10.1111/anae.14056. Epub 2017 Sep 22.
citation: Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 2015 Mar;47(3):447-54. doi: 10.1093/ejcts/ezu193. Epub 2014 May 7.
citation: Serraino GF, Murphy GJ. Effects of cerebral near-infrared spectroscopy on the outcome of patients undergoing cardiac surgery: a systematic review of randomised trials. BMJ Open. 2017 Sep 7;7(9):e016613. doi: 10.1136/bmjopen-2017-016613.
citation: Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.