title: The Effect of Patient-Specific Cerebral Oxygenation Monitoring on Postoperative Cognitive Function: A Multicenter Randomized Controlled Trial.
abstract: BACKGROUND
  Indices of global tissue oxygen delivery and utilization such as mixed venous oxygen saturation, serum lactate concentration, and arterial hematocrit are commonly used to determine the adequacy of tissue oxygenation during cardiopulmonary bypass (CPB). However, these global measures may not accurately reflect regional tissue oxygenation and ischemic organ injury remains a common and serious complication of CPB. Near-infrared spectroscopy (NIRS) is a noninvasive technology that measures regional tissue oxygenation. NIRS may be used alongside global measures to optimize regional perfusion and reduce organ injury. It may also be used as an indicator of the need for red blood cell transfusion in the presence of anemia and tissue hypoxia. However, the clinical benefits of using NIRS remain unclear and there is a lack of high-quality evidence demonstrating its efficacy and cost effectiveness.
  
  
  OBJECTIVE
  The aim of the patient-specific cerebral oxygenation monitoring as part of an algorithm to reduce transfusion during heart valve surgery (PASPORT) trial is to determine whether the addition of NIRS to CPB management algorithms can prevent cognitive decline, postoperative organ injury, unnecessary transfusion, and reduce health care costs.
  
  
  METHODS
  Adults aged 16 years or older undergoing valve or combined coronary artery bypass graft and valve surgery at one of three UK cardiac centers (Bristol, Hull, or Leicester) are randomly allocated in a 1:1 ratio to either a standard algorithm for optimizing tissue oxygenation during CPB that includes a fixed transfusion threshold, or a patient-specific algorithm that incorporates cerebral NIRS monitoring and a restrictive red blood cell transfusion threshold. Allocation concealment, Internet-based randomization stratified by operation type and recruiting center, and blinding of patients, ICU and ward care staff, and outcome assessors reduce the risk of bias. The primary outcomes are cognitive function 3 months after surgery and infectious complications during the first 3 months after surgery. Secondary outcomes include measures of inflammation, organ injury, and volumes of blood transfused. The cost effectiveness of the NIRS-based algorithm is described in terms of a cost-effectiveness acceptability curve. The trial tests the superiority of the patient-specific algorithm versus standard care. A sample size of 200 patients was chosen to detect a small to moderate target difference with 80% power and 5% significance (two tailed).
  
  
  RESULTS
  Over 4 years, 208 patients have been successfully randomized and have been followed up for a 3-month period. Results are to be reported in 2015.
  
  
  CONCLUSIONS
  This study provides high-quality evidence, both valid and widely applicable, to determine whether the use of NIRS monitoring as part of a patient-specific management algorithm improves clinical outcomes and is cost effective.
  
  
  BACKGROUND
  International Standard Randomized Controlled Trial Number (ISRCTN): 23557269; http://www.isrctn.com/ISRCTN23557269 (Archived by Webcite at http://www.webcitation.org/6buyrbj64).
authors.affiliation: Clinical Trials & Evaluation Unit, University of Bristol, Bristol, United Kingdom.
authors.forename: Lucy
authors.identifier: http://orcid.org/0000-0001-8179-5172
authors.initials: L
authors.lastname: Ellis
authors.forename: Gavin J
authors.identifier: http://orcid.org/0000-0003-0976-1482
authors.initials: GJ
authors.lastname: Murphy
authors.forename: Lucy
authors.identifier: http://orcid.org/0000-0002-9255-6617
authors.initials: L
authors.lastname: Culliford
authors.forename: Lucy
authors.identifier: http://orcid.org/0000-0001-7269-1945
authors.initials: L
authors.lastname: Dreyer
authors.forename: Gemma
authors.identifier: http://orcid.org/0000-0002-9525-2758
authors.initials: G
authors.lastname: Clayton
authors.forename: Richard
authors.identifier: http://orcid.org/0000-0002-0476-1718
authors.initials: R
authors.lastname: Downes
authors.forename: Eamonn
authors.identifier: http://orcid.org/0000-0002-4708-936X
authors.initials: E
authors.lastname: Nicholson
authors.forename: Serban
authors.identifier: http://orcid.org/0000-0002-0456-1249
authors.initials: S
authors.lastname: Stoica
authors.forename: Barnaby C
authors.identifier: http://orcid.org/0000-0002-5101-9487
authors.initials: BC
authors.lastname: Reeves
authors.forename: Chris A
authors.identifier: http://orcid.org/0000-0002-9624-2615
authors.initials: CA
authors.lastname: Rogers
keywords: asepsis; cardiac surgery; cardiopulmonary bypass; cerebral oxygenation; cognition; coronary artery; infection; randomized clinical trial; transfusion; valve