The Clinical Effects of Cerebral Near-Infrared Spectroscopy Monitoring (NIRS) Versus No Monitoring in Children and Adults: A Protocol for a Systematic Review With Meta-Analysis and Trial Sequential Analysis

Abstract BackgroundMultiple clinical conditions are associated with cerebral hypoxia/ischaemia and thereby an increased risk of hypoxic-ischaemic brain injury. Cerebral near-infrared spectroscopy monitoring (NIRS) is a tool to monitor brain oxygenation and perfusion, and the clinical uptake of NIRS has expanded over recent years. Specifically, NIRS is used in the perioperative and neonatal, paediatric, and adult intensive care settings. However, the available literature suggests that clinical benefits and harms of cerebral NIRS monitoring are uncertain. As rates of clinically significant hypoxic-ischaemic brain injuries are typically low, it is difficult for randomised clinical trials to capture a sufficiently large number of events to evaluate the clinical effect of cerebral NIRS monitoring, when focusing on specific clinical settings. MethodsWe will conduct a systematic review with meta-analysis and Trial Sequential Analysis to evaluate the benefits and harms of clinical care with cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings. We will only include randomised clinical trials and the primary outcomes are all-cause mortality, moderate or severe persistent cognitive or neurological deficit, and proportion of participants with one or more serious adverse events. The review will be conducted according to the methodology described in The Cochrane Handbook for Systematic Reviews of Interventions, including GRADE. An eight-step procedure by Jakobsen et al. will be used to assess if thresholds for statistical and clinical significance are crossed.DiscussionAs we include trials across multiple clinical settings, there is an increased probability of reaching a sufficient information size. However, heterogeneity between the included trials may impair our ability to interpret results to specific clinical settings. In this situation, we may have to depend on subgroup analyses with inherent increased risks of type I and II errors. Systematic review registrationThis systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) (1,2) on 12th of October 2020.