Hansen Mathias Lühr, Hyttel-Sørensen Simon, Jakobsen Janus Christian, Gluud Christian, Kooi Elisabeth M W, Mintzer Jonathan, de Boode Willem P, Fumagalli Monica, Alarcon Ana, Alderliesten Thomas, Greisen Gorm
Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Department of Intensive Care, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Syst Rev. 2021 Apr 16;10(1):111. doi: 10.1186/s13643-021-01660-2.
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.
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).
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.
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 ).
多种临床病症与脑缺氧/缺血相关，从而增加了缺氧缺血性脑损伤的风险。脑近红外光谱监测（NIRS）是一种监测脑氧合和灌注的工具，近年来NIRS在临床上的应用有所扩大。具体而言，NIRS用于新生儿、儿科以及成人围手术期和重症监护环境。然而，现有文献表明，脑NIRS监测的临床益处和危害尚不确定。由于具有临床意义的缺氧缺血性脑损伤发生率通常较低，当聚焦于特定临床环境时，随机临床试验很难捕捉到足够多的事件来评估脑NIRS监测的临床效果。本系统评价的目的是评估在所有临床环境中，有脑NIRS监测的临床护理与无脑NIRS监测的临床护理相比的益处和危害，涉及儿童和成人。
我们将进行一项包含荟萃分析和试验序贯分析的系统评价。我们将仅纳入随机临床试验。主要结局包括全因死亡率、中度或重度持续性认知或神经功能缺损，以及发生一项或多项严重不良事件的参与者比例。我们将检索Cochrane中心对照试验注册库（CENTRAL）、荷兰医学文摘数据库（EMBASE）、美国国立医学图书馆医学期刊数据库（MEDLINE）以及自创建以来的科学引文索引扩展版。两名评价员将独立筛选所有引文、全文文章并提取数据。将使用Cochrane偏倚风险工具2.版本评估偏倚风险。如果可行，我们将对结局数据进行随机效应荟萃分析和固定效应荟萃分析。还将进行额外分析以探索异质性的潜在来源（例如偏倚风险、临床环境）。
由于我们纳入了多个临床环境中的试验，达到足够信息规模的可能性增加。然而，纳入试验之间的异质性可能会削弱我们将结果解读到特定临床环境的能力。在这种情况下，我们可能不得不依赖亚组分析，但这会固有地增加I型和II型错误的风险。
国际系统评价前瞻性注册库（PROSPERO）CRD42020202986。本系统评价方案已于2020年10月12日提交至国际系统评价前瞻性注册库（PROSPERO）（http://www.crd.york.ac.uk/prospero）并于2020年11月12日发表（注册编号CRD42020202986）。
