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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

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@article{8017a3257201477c8b1b2abae1816d9e,
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",
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 ).",
keywords = "Adult, Brain, Child, Humans, Infant, Newborn, Lung, Meta-Analysis as Topic, Spectroscopy, Near-Infrared, Systematic Reviews as Topic, Intensive care, Neonatal intensive care, Systematic review, Meta-analysis, Anaesthesia, Hypoxic-ischaemic brain injury, Surgery, Cerebral NIRS monitoring, Trial sequential analysis, Cerebral oxygenation monitoring",
author = "Hansen, {Mathias L{\"u}hr} and Simon Hyttel-S{\o}rensen and Jakobsen, {Janus Christian} and Christian Gluud and Kooi, {Elisabeth M W} and Jonathan Mintzer and {de Boode}, {Willem P} and Monica Fumagalli and Ana Alarcon and Thomas Alderliesten and Gorm Greisen",
year = "2021",
month = apr,
day = "16",
doi = "10.1186/s13643-021-01660-2",
language = "English",
volume = "10",
pages = "111",
journal = "Systematic Reviews",
issn = "2046-4053",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - The clinical effects of cerebral near-infrared spectroscopy monitoring (NIRS) versus no monitoring

T2 - a protocol for a systematic review with meta-analysis and trial sequential analysis

AU - Hansen, Mathias Lühr

AU - Hyttel-Sørensen, Simon

AU - Jakobsen, Janus Christian

AU - Gluud, Christian

AU - Kooi, Elisabeth M W

AU - Mintzer, Jonathan

AU - de Boode, Willem P

AU - Fumagalli, Monica

AU - Alarcon, Ana

AU - Alderliesten, Thomas

AU - Greisen, Gorm

PY - 2021/4/16

Y1 - 2021/4/16

N2 - 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 ).

AB - 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 ).

KW - Adult

KW - Brain

KW - Child

KW - Humans

KW - Infant, Newborn

KW - Lung

KW - Meta-Analysis as Topic

KW - Spectroscopy, Near-Infrared

KW - Systematic Reviews as Topic

KW - Intensive care

KW - Neonatal intensive care

KW - Systematic review

KW - Meta-analysis

KW - Anaesthesia

KW - Hypoxic-ischaemic brain injury

KW - Surgery

KW - Cerebral NIRS monitoring

KW - Trial sequential analysis

KW - Cerebral oxygenation monitoring

UR - http://www.scopus.com/inward/record.url?scp=85104380804&partnerID=8YFLogxK

U2 - 10.1186/s13643-021-01660-2

DO - 10.1186/s13643-021-01660-2

M3 - Journal article

C2 - 33863369

VL - 10

SP - 111

JO - Systematic Reviews

JF - Systematic Reviews

SN - 2046-4053

IS - 1

M1 - 111

ER -

ID: 67052682