title: Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.
abstract: BACKGROUND
  Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations.
  
  
  METHODS
  Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events.
  
  
  RESULTS
  Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups.
  
  
  CONCLUSIONS
  Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.
authors.affiliation: From the Department of Anesthesiology (A. Deschamps, A. Denault) and Department of Intensive Care Medicine (A. Denault), Montreal Heart Institute, University of Montreal, Montreal, Quebec, Canada; Department of Anesthesiology and Critical Care Medicine, Queen Elizabeth II Health Science Centre, Dalhousie University, Halifax, Canada (R.H.); Department of Anesthesiology, University of Manitoba, St. Boniface Hospital, Winnipeg, Manitoba, Canada (H.G.); Department of Anesthesia, University of Toronto, Keenan Research Centre for Biomedical Science, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada (C.D.M.); Department of Anesthesiology Pharmacology and Therapeutics, University of British Columbia, Vancouver, British Columbia, Canada (P.T.C.); Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, and Population Health and Optimal Health Practices, CHU de Québec Research Center, CHU de Québec, Université Laval, Quebec City, Quebec, Canada (A.F.T.); Department of Anesthesiology, CHU de Sherbrooke, Université de Sherbrooke, Sherbrooke, Quebec, Canada (E.d.M.); Department of Anesthesiology, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, Quebec, Canada (J.S.B.); Department of Anesthesiology, Ottawa Heart Institute, University of Ottawa, Ottawa, Ontario, Canada (C.H.); Department of Anesthesiology, McMaster University, Hamilton, Ontario, Canada (S.S.); Department of Anesthesiology, Calgary Foothills Hospital, University of Calgary, Calgary, Alberta, Canada (D.S.); Department of Anesthesiology, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada (S.H.); and Department of Social and Preventive Medicine, University of Montreal, Montreal, Quebec, Canada (J.L.).Montreal Heart Institute, Montreal, QuébecUniversity of Manitoba, Winnipeg, ManitobaUniversité Laval, Québec, QuébecPh.D., Montreal Heart Institute, Montreal, Qu
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mesh_terms: D000368:Aged; D000465:Algorithms; D006348:Cardiac Surgical Procedures; D002560:Cerebrovascular Circulation / Q000502:physiology*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D016343:Monitoring, Intraoperative / Q000379:methods*; D010092:Oximetry / Q000379:methods*; D010100:Oxygen / Q000097:blood*; D010101:Oxygen Consumption / Q000502:physiology; D011446:Prospective Studies; D012306:Risk
chemical_list: D010100:Oxygen