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Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.
Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C. Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it. |
|
| Control | Placebo Comparator | Only cerebral NIRS monitoring by means of FORE-SIGHT Universal Cerebral Oximeter MC-2030C during cardiac surgery and the first six hours after it. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Correction rSO2 desaturation. | Other | Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it. In case of rSO2 decrease less than 60% correct: head position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood < 35 mmHg; mean arterial pressure < 60 mmHg; central venous pressure > 10 mmHg; cardiac index < 2.0 l/min/m2; mixed venous oxygen saturation < 60%; hemoglobin < 65 g/L during cardiopulmonary bypass or hemoglobin < 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications | This composite outcome includes: myocardial infarction, stroke, delirium, postoperative cognitive dysfunction, wound infection, mediastinitis, mechanical ventilation more than 24 h, arrhythmia, reoperation for bleeding, acute kidney injury, and acute kidney injury requiring dialysis. | Up to 30 day after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major organ morbidity and mortality | This outcome includes: stroke, acute kidney injury requiring dialysis, mechanical ventilation more than 48 h, mediastinitis, reoperation, and death | Up to 30 day after randomization |
| Duration of intensive care unit stay |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of desaturation episodes | Desaturation is defined as level of rSO2 less than 60%. | Intra operative |
| Severity of desaturation episodes | Severity is defined as the product of length of time and depth of rSO2 less than 60% |
Inclusion Criteria:
High-risk cardiac surgery patients as determined by at least one of the followings:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir V Lomivorotov, Prof | Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology | Novosibirsk | Novosibirsk Territory | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17179242 | Background | 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. | |
| 15578464 | Background | Yao FS, Tseng CC, Ho CY, Levin SK, Illner P. Cerebral oxygen desaturation is associated with early postoperative neuropsychological dysfunction in patients undergoing cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Oct;18(5):552-8. doi: 10.1053/j.jvca.2004.07.007. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard treatment | Other | Standard treatment |
|
| Up to 30 day after randomization |
| Duration of postoperative hospital stay | Up to 30 day after randomization |
| Death from all causes at 30 days | Up to 30 day after randomisation |
| Intra operative |
| 19101265 | Background | 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. |
| 20579669 | Background | Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25. |
| 21178669 | Background | Heringlake M, Garbers C, Kabler JH, Anderson I, Heinze H, Schon J, Berger KU, Dibbelt L, Sievers HH, Hanke T. Preoperative cerebral oxygen saturation and clinical outcomes in cardiac surgery. Anesthesiology. 2011 Jan;114(1):58-69. doi: 10.1097/ALN.0b013e3181fef34e. |
| 18270192 | Background | Denault A, Deschamps A, Murkin JM. A proposed algorithm for the intraoperative use of cerebral near-infrared spectroscopy. Semin Cardiothorac Vasc Anesth. 2007 Dec;11(4):274-81. doi: 10.1177/1089253207311685. |