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.
Bibliografisk noteFunding Information:
This study is funded as part of the SafeBoosC-III project (safeboosc.eu). The Elsass Foundation supports the SafeBoosC-III project through an unconditional and unrestricted grant of DKK 2,700,000.00; the Svend Andersen Foundation with an unconditional and unrestricted grant of DKK 1,000,000.00; and Aage and Johanne Louis-Hansen Foundation with an unconditional and unrestricted grant of DKK 1,000,000,00. These funding sources had no role in the design, execution, analyses, interpretation of the data, or decision to submit the results of this systematic review. Financial support of publication costs by the European Society for Paediatric Research is gratefully acknowledged.
© 2022, The Author(s).