Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

Journal: Anesthesiology

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.

Richard Hall, Hilary Grocott, C Mazer, Peter Choi, Jean Bussières, Summer Syed, Doug Seal, Stuart Herd, Jean Lambert, André Denault, Alain Deschamps, Alan Mutch, Alexis Turgeon, Andrea Todd, Angela Jerath, Ashraf Fayad, Barry Finnegan, Blaine Kent, Brent Kennedy, Brian Cuthbertson, Brian Kavanagh, Brian Warriner, Charles Macadams, Christian Lehmann, Christine Fudorow, Christopher Hudson, Colin Mccartney, Dan Mcisaac, Daniel Dubois, David Campbell, David Mazer, David Neilpovitz, David Rosen, Davy Cheng, Dennis Drapeau, Derek Dillane, Diem Tran, Dolores Mckeen, Duminda Wijeysundera, Eric Jacobsohn, Etienne Couture, Etienne De Medicis, Fahad Alam, Faraj Abdallah, Fiona Ralley, Frances Chung, Francois Lellouche, Gary Dobson, Genevieve Germain, George Djaiani, Ian Gilron, Gregory Hare, Gregory Bryson, Hance Clarke, Heather Mcdonald, Helen Roman Smith, Homer Yang, James Douketis, James Paul, Jean Beaubien, Jeremy Pridham, J Armstrong, Joel Parlow, John Murkin, Jonathan Gamble, Kaylene Duttchen, Keyvan Karkouti, Kim Turner, Leyla Baghirzada, Linda Szabo, Manoj Lalu, Marcin Wasowicz, Michael Bautista, Michael Jacka, Michael Murphy, Michael Schmidt, Michaël Verret, Michel-antoine Perrault, Nicolas Beaudet, Norman Buckley, Peter Choi, Peter Macdougall, Philip Jones, Pierre Drolet, Pierre Beaulieu, Ravi Taneja, Rene Martin, Ronald George, Rosa Chun, Sarah Mcmullen, Scott Beattie, Sonia Sampson, Stephen Choi, Stephen Kowalski, Stuart Mccluskey, Sylvain Boet, Tim Ramsay, Tarit Saha, Thomas Mutter, Tumul Chowdhury, Vishal Uppal, William Mckay

Similar Publications