CHU de Québec - Université Laval Research Center, Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Université Laval, Quebec City, Quebec, Canada.
Department of Medicine, Université Laval, Quebec City, Quebec, Canada.
BMJ Open. 2020 Nov 10;10(11):e043300. doi: 10.1136/bmjopen-2020-043300.
Aneurysmal subarachnoid haemorrhage (aSAH) is a devastating disease associated with high mortality and morbidity. The main threat to patients is delayed cerebral ischaemia (DCI). Near-infrared spectroscopy (NIRS) is a recent technology allowing continuous, non-invasive cerebral oximetry that could permit timely detection of impending DCI and appropriate intervention to improve outcomes. However, the ability of regional oxygen saturation to detect DCI, its association to the outcome, or benefits of any interventions based on NIRS data, are lacking. Our aims are to evaluate NIRS technology both as a therapeutic tool to improve outcomes in aSAH patients and as a diagnostic tool for DCI.
MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews will be searched from their inception and without language restriction. Our search strategy will cover the themes of subarachnoid haemorrhage and cerebral oximetry, without limitations regarding studied outcomes. We will identify all observational and interventional human studies of adult patients hospitalised after aSAH that were monitored using NIRS. Functional outcome measures, including the modified Rankin Scale, the Glasgow Outcome Scale and the Barthel Index, will constitute the primary outcome. The Cochrane Risk of Bias tool will be used for randomised controlled trials, the ROBINS-I tool to assess non-randomised studies of interventions and the Newcastle-Ottawa Scale for cohort or case-control studies. The Quality Assessment of Diagnostic Accuracy Studies-2 will be applied to studies evaluating NIRS diagnostic accuracy for DCI. We will evaluate the quality of the evidence of the effect based on the Grading of Recommendations Assessment, Development and Evaluation methodology.
Dissemination will proceed through submission for journal publication, trial registry completion and abstract presentation. Ethics approval is not required.
CRD42020077522.
动脉瘤性蛛网膜下腔出血（aSAH）是一种死亡率和发病率都很高的毁灭性疾病。对患者的主要威胁是迟发性脑缺血（DCI）。近红外光谱（NIRS）是一种最近的技术，可以进行连续的、非侵入性的脑氧合监测，从而可以及时发现即将发生的 DCI，并进行适当的干预以改善预后。然而，区域氧饱和度检测 DCI 的能力、与结局的关系，或者基于 NIRS 数据的任何干预措施的益处，都尚未可知。我们的目的是评估 NIRS 技术作为改善 aSAH 患者预后的治疗工具，以及作为 DCI 的诊断工具。
将从建库开始，对 MEDLINE、EMBASE、Web of Science、Cochrane 中央对照试验注册库和 Cochrane 系统评价数据库进行无语言限制的检索。我们的检索策略将涵盖蛛网膜下腔出血和脑氧合这两个主题，而不限制研究结果。我们将确定所有使用 NIRS 监测的成年 aSAH 后住院患者的观察性和干预性人体研究。功能结局测量，包括改良 Rankin 量表、格拉斯哥结局量表和巴氏指数，将构成主要结局。随机对照试验将使用 Cochrane 偏倚风险工具进行评估，非随机干预研究将使用 ROBINS-I 工具进行评估，队列或病例对照研究将使用纽卡斯尔-渥太华量表进行评估。用于评估 NIRS 对 DCI 诊断准确性的研究将应用诊断准确性研究质量评估-2。我们将根据推荐评估、制定和评估方法学对基于效果的证据质量进行评估。
传播将通过提交期刊发表、试验注册完成和摘要展示进行。不需要伦理批准。
PROSPERO 注册号： CRD42020077522。
