C A Rogers1, S Stoica2, L Ellis1, E A Stokes3, S Wordsworth3, L Dabner1, G Clayton1, R Downes2, E Nicholson2, S Bennett4, G D Angelini2, B C Reeves1, G J Murphy5. 1. Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK. 2. Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK. 3. Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Old Road, Headington, Oxford OX3?7LF, UK. 4. Cardiac Anaesthesia and Intensive Care, King Faisal Cardiac Center, NGHA, Jeddah, Saudi Arabia. 5. Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester LE3?9QP, UK.
Abstract
BACKGROUND: We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain, heart, and kidneys. METHODS: In a randomized controlled trial, participants in three UK centres were randomized with concealed allocation to a NIRS (INVOS 5100; Medtronic Inc., Minneapolis, MN, USA)-based 'patient-specific' algorithm that included a restrictive red cell transfusion threshold (haematocrit 18%) or to a 'generic' non-NIRS-based algorithm (standard care). The NIRS algorithm aimed to maintain cerebral oxygenation at an absolute value of > 50% or at > 70% of baseline values. The primary outcome for the trial was cognitive function measured up to 3 months postsurgery. RESULTS: The analysis population comprised eligible randomized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n =98 patient-specific algorithm; n =106 generic algorithm). There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills. The NIRS group had higher scores for verbal fluency; mean difference 3.73 (95% confidence interval 1.50, 5.96). Red cell transfusions, biomarkers of brain, kidney, and myocardial injury, adverse events, and health-care costs were similar between the groups. CONCLUSIONS: These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery. CLINICAL TRIAL REGISTRATION: http://www.controlled-trials.com , ISRCTN 23557269.
BACKGROUND: We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain, heart, and kidneys. METHODS: In a randomized controlled trial, participants in three UK centres were randomized with concealed allocation to a NIRS (INVOS 5100; Medtronic Inc., Minneapolis, MN, USA)-based 'patient-specific' algorithm that included a restrictive red cell transfusion threshold (haematocrit 18%) or to a 'generic' non-NIRS-based algorithm (standard care). The NIRS algorithm aimed to maintain cerebral oxygenation at an absolute value of > 50% or at > 70% of baseline values. The primary outcome for the trial was cognitive function measured up to 3 months postsurgery. RESULTS: The analysis population comprised eligible randomized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n =98 patient-specific algorithm; n =106 generic algorithm). There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills. The NIRS group had higher scores for verbal fluency; mean difference 3.73 (95% confidence interval 1.50, 5.96). Red cell transfusions, biomarkers of brain, kidney, and myocardial injury, adverse events, and health-care costs were similar between the groups. CONCLUSIONS: These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery. CLINICAL TRIAL REGISTRATION: http://www.controlled-trials.com , ISRCTN 23557269.
Authors: Elizabeth Mahanna-Gabrielli; Katie J Schenning; Lars I Eriksson; Jeffrey N Browndyke; Clinton B Wright; Deborah J Culley; Lis Evered; David A Scott; Nae Yah Wang; Charles H Brown; Esther Oh; Patrick Purdon; Sharon Inouye; Miles Berger; Robert A Whittington; Catherine C Price; Stacie Deiner Journal: Br J Anaesth Date: 2019-08-19 Impact factor: 9.166
Authors: Mathias Lühr Hansen; Simon Hyttel-Sørensen; Janus Christian Jakobsen; Christian Gluud; Elisabeth M W Kooi; Jonathan Mintzer; Willem P de Boode; Monica Fumagalli; Ana Alarcon; Thomas Alderliesten; Gorm Greisen Journal: Pediatr Res Date: 2022-02-22 Impact factor: 3.756