Mathias Lühr Hansen1, Simon Hyttel-Sørensen2, Janus Christian Jakobsen3,4, Christian Gluud3,4, Elisabeth M W Kooi5, Jonathan Mintzer6, Willem P de Boode7, Monica Fumagalli8,9, Ana Alarcon10, Thomas Alderliesten11, Gorm Greisen12. 1. Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. mathias.luhr.hansen@gmail.com. 2. Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. 3. Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. 4. Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 5. Division of Neonatology, University of Groningen, University Medical Center Groningen, Beatrix Children's Hospital, Groningen, the Netherlands. 6. Department of Pediatrics, Division of Newborn Medicine, Mountainside Medical Center, Montclair, NJ, USA. 7. Division of Neonatology, Department of Pediatrics, Radboud University Medical Center, Radboud Institute for Health Sciences, Amalia Children's Hospital, Nijmegen, the Netherlands. 8. Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Via Francesco Sforza 35, 20122, Milano, Italy. 9. Department of Clinical Sciences and Community Health, University of Milan, Via Festa del Perdono 7, 20122, Milano, Italy. 10. Department of Neonatology, Hospital Sant Joan de Deu, Passeig de Sant Joan de Deu 2, 08950, Esplugues de Llobregat, Barcelona, Spain. 11. Department of Neonatology, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, the Netherlands. 12. Department of Neonatology, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Abstract
BACKGROUND: Cerebral oxygenation monitoring utilising near-infrared spectroscopy (NIRS) is increasingly used to guide interventions in clinical care. The objective of this systematic review with meta-analysis and Trial Sequential Analysis is to evaluate the effects of clinical care with access to cerebral NIRS monitoring in children and adults versus care without. METHODS: This review conforms to PRISMA guidelines and was registered in PROSPERO (CRD42020202986). Methods are outlined in our protocol (doi: 10.1186/s13643-021-01660-2). RESULTS: Twenty-five randomised clinical trials were included (2606 participants). All trials were at a high risk of bias. Two trials assessed the effects of NIRS during neonatal intensive care, 13 during cardiac surgery, 9 during non-cardiac surgery and 1 during neurocritical care. Meta-analyses showed no significant difference for all-cause mortality (RR 0.75, 95% CI 0.51-1.10; 1489 participants; I2 = 0; 11 trials; very low certainty of evidence); moderate or severe, persistent cognitive or neurological deficit (RR 0.74, 95% CI 0.42-1.32; 1135 participants; I2 = 39.6; 9 trials; very low certainty of evidence); and serious adverse events (RR 0.82; 95% CI 0.67-1.01; 2132 participants; I2 = 68.4; 17 trials; very low certainty of evidence). CONCLUSION: The evidence on the effects of clinical care with access to cerebral NIRS monitoring is very uncertain. IMPACT: The evidence of the effects of cerebral NIRS versus no NIRS monitoring are very uncertain for mortality, neuroprotection, and serious adverse events. Additional trials to obtain sufficient information size, focusing on lowering bias risk, are required. The first attempt to systematically review randomised clinical trials with meta-analysis to evaluate the effects of cerebral NIRS monitoring by pooling data across various clinical settings. Despite pooling data across clinical settings, study interpretation was not substantially impacted by heterogeneity. We have insufficient evidence to support or reject the clinical use of cerebral NIRS monitoring.
BACKGROUND: Cerebral oxygenation monitoring utilising near-infrared spectroscopy (NIRS) is increasingly used to guide interventions in clinical care. The objective of this systematic review with meta-analysis and Trial Sequential Analysis is to evaluate the effects of clinical care with access to cerebral NIRS monitoring in children and adults versus care without. METHODS: This review conforms to PRISMA guidelines and was registered in PROSPERO (CRD42020202986). Methods are outlined in our protocol (doi: 10.1186/s13643-021-01660-2). RESULTS: Twenty-five randomised clinical trials were included (2606 participants). All trials were at a high risk of bias. Two trials assessed the effects of NIRS during neonatal intensive care, 13 during cardiac surgery, 9 during non-cardiac surgery and 1 during neurocritical care. Meta-analyses showed no significant difference for all-cause mortality (RR 0.75, 95% CI 0.51-1.10; 1489 participants; I2 = 0; 11 trials; very low certainty of evidence); moderate or severe, persistent cognitive or neurological deficit (RR 0.74, 95% CI 0.42-1.32; 1135 participants; I2 = 39.6; 9 trials; very low certainty of evidence); and serious adverse events (RR 0.82; 95% CI 0.67-1.01; 2132 participants; I2 = 68.4; 17 trials; very low certainty of evidence). CONCLUSION: The evidence on the effects of clinical care with access to cerebral NIRS monitoring is very uncertain. IMPACT: The evidence of the effects of cerebral NIRS versus no NIRS monitoring are very uncertain for mortality, neuroprotection, and serious adverse events. Additional trials to obtain sufficient information size, focusing on lowering bias risk, are required. The first attempt to systematically review randomised clinical trials with meta-analysis to evaluate the effects of cerebral NIRS monitoring by pooling data across various clinical settings. Despite pooling data across clinical settings, study interpretation was not substantially impacted by heterogeneity. We have insufficient evidence to support or reject the clinical use of cerebral NIRS monitoring.
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Authors: Barbara J Stoll; Nellie I Hansen; Edward F Bell; Michele C Walsh; Waldemar A Carlo; Seetha Shankaran; Abbot R Laptook; Pablo J Sánchez; Krisa P Van Meurs; Myra Wyckoff; Abhik Das; Ellen C Hale; M Bethany Ball; Nancy S Newman; Kurt Schibler; Brenda B Poindexter; Kathleen A Kennedy; C Michael Cotten; Kristi L Watterberg; Carl T D'Angio; Sara B DeMauro; William E Truog; Uday Devaskar; Rosemary D Higgins Journal: JAMA Date: 2015-09-08 Impact factor: 56.272