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01-12-2021 | Hypoxic-Ischemic Brain Injury | Protocol

The clinical effects of cerebral near-infrared spectroscopy monitoring (NIRS) versus no monitoring: a protocol for a systematic review with meta-analysis and trial sequential analysis

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

Published in: Systematic Reviews | Issue 1/2021

Abstract

Background

Multiple 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 neonatal, paediatric, and adult perioperative and 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. The aim of this systematic review will be to evaluate the benefits and harms of clinical care with access to cerebral NIRS monitoring versus clinical care without cerebral NIRS monitoring in children and adults across all clinical settings.

Methods

We will conduct a systematic review with meta-analysis and trial sequential analysis. We will only include randomised clinical trials. 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. We will search CENTRAL, EMBASE, MEDLINE, and the Science Citation Index Expanded from their inception and onwards. Two reviewers will independently screen all citations, full-text articles, and extract data. The risk of bias will be appraised using the Cochrane risk of bias tool version 2.0. If feasible, we will conduct both random-effects meta-analysis and fixed-effect meta-analysis of outcome data. Additional analysis will be conducted to explore the potential sources of heterogeneity (e.g. risk of bias, clinical setting).

Discussion

As 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 registration

PROSPERO CRD42020202986. This systematic review protocol has been submitted for registration in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk/prospero) on the 12th of October 2020 and published on the 12th of November 2020 (registration ID CRD42020202986).

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Title: The clinical effects of cerebral near-infrared spectroscopy monitoring (NIRS) versus no monitoring: a protocol for a systematic review with meta-analysis and trial sequential analysis
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
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Hypoxic-Ischemic Brain Injury
Published in: Systematic Reviews / Issue 1/2021
Electronic ISSN: 2046-4053
DOI: https://doi.org/10.1186/s13643-021-01660-2

At a glance: The STEP trials

Springer Medicine

The clinical effects of cerebral near-infrared spectroscopy monitoring (NIRS) versus no monitoring: a protocol for a systematic review with meta-analysis and trial sequential analysis

Abstract

Background

Methods

Discussion

Systematic review registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Systematic review registration

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