Romero-Garcia Nekane, Robba Chiara, Monleon Berta, Ruiz-Zarco Ana, Ruiz-Pacheco Alberto, Pascual-Gonzalez Maria, Perdomo Felipe, Garcia-Perez Maria Luisa, Taccone Fabio Silvio, Badenes Rafael
Anesthesiology and Surgical-Trauma Intensive Care, Hospital Clinic Universitari de València, Valencia, Spain
Department of Surgery. School of Medicine, University of Valencia, Valencia, Spain.
BMJ Open. 2024 Jul 17;14(7):e084849. doi: 10.1136/bmjopen-2024-084849.
Oxygen is frequently prescribed in neurocritical care units. Avoiding hypoxaemia is a key objective in patients with acute brain injury (ABI). However, several studies suggest that hyperoxaemia may also be related to higher mortality and poor neurological outcomes in these patients. The evidence in this direction is still controversial due to the limited number of prospective studies, the lack of a common definition for hyperoxaemia, the heterogeneity in experimental designs and the different causes of ABI. To explore the correlation between hyperoxaemia and poor neurological outcomes and mortality in hospitalised adult patients with ABI, we will conduct a systematic review and meta-analysis of observational studies and RCTs.
The systematic review methods have been defined according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and follow the PRISMA-Protocols structure. Studies published until June 2024 will be identified in the electronic databases MEDLINE, Embase, Scopus, Web of Science, The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature and ClinicalTrials.gov. Retrieved records will be independently screened by four authors working in pairs, and the selected variables will be extracted from studies reporting data on the effect of 'hyperoxaemia' versus 'no hyperoxaemia on neurological outcomes and mortality in hospitalised patients with ABI. We will use covariate-adjusted ORs as outcome measures when reported since they account for potential cofounders and provide a more accurate estimate of the association between hyperoxaemia and outcomes; when not available, we will use univariate ORs. If the study presents the results as relative risks, it will be considered equivalent to the OR as long as the prevalence of the condition is close to 10%. Pooled estimates of both outcomes will be calculated applying random-effects meta-analysis. Interstudy heterogeneity will be assessed using the I statistic; risk of bias will be assessed through Risk Of Bias In Non-Randomised Studies of Interventions, Newcastle-Ottawa or RoB2 tools. Depending on data availability, we plan to conduct subgroup analyses by ABI type (traumatic brain injury, postcardiac arrest, subarachnoid haemorrhage, intracerebral haemorrhage and ischaemic stroke), arterial partial pressure of oxygen values, study quality, study time, neurological scores and other selected clinical variables of interest.
Specific ethics approval consent is not required as this is a review of previously published anonymised data. Results of the study will be shared with the scientific community via publication in a peer-reviewed journal and presentation at relevant conferences and workshops. It will also be shared key stakeholders, such as national or international health authorities, healthcare professionals and the general population, via scientific outreach journals and research institutes' newsletters.
神经重症监护病房经常会给患者吸氧。避免低氧血症是急性脑损伤(ABI)患者的关键目标。然而,多项研究表明,高氧血症也可能与这些患者较高的死亡率和不良神经学预后相关。由于前瞻性研究数量有限、缺乏高氧血症的通用定义、实验设计的异质性以及ABI的不同病因,这方面的证据仍存在争议。为了探究住院成年ABI患者高氧血症与不良神经学预后及死亡率之间的相关性,我们将对观察性研究和随机对照试验进行系统评价和荟萃分析。
系统评价方法已根据系统评价和荟萃分析的首选报告项目(PRISMA)指南进行定义,并遵循PRISMA方案结构。截至2024年6月发表的研究将在电子数据库MEDLINE、Embase、Scopus、科学网、考克兰图书馆、护理及相关健康文献累积索引和ClinicalTrials.gov中进行检索。检索到的记录将由四位作者两两独立筛选,选定的变量将从报告“高氧血症”与“无高氧血症”对住院ABI患者神经学预后和死亡率影响数据的研究中提取。如果报告了协变量调整后的比值比(OR),我们将其用作结局指标,因为它们考虑了潜在的混杂因素,并能更准确地估计高氧血症与结局之间的关联;如果没有,则使用单变量OR。如果研究将结果表示为相对风险,只要疾病患病率接近10%,就将其视为等同于OR。将应用随机效应荟萃分析计算两种结局的合并估计值。将使用I统计量评估研究间的异质性;将通过干预性非随机研究的偏倚风险、纽卡斯尔-渥太华或RoB2工具评估偏倚风险。根据数据可用性,我们计划按ABI类型(创伤性脑损伤、心脏骤停后、蛛网膜下腔出血、脑出血和缺血性卒中)、动脉血氧分压值、研究质量、研究时间、神经学评分以及其他选定的感兴趣的临床变量进行亚组分析。
由于这是对先前发表的匿名数据的综述,无需特定的伦理批准同意。研究结果将通过在同行评审期刊上发表以及在相关会议和研讨会上展示与科学界分享。还将通过科学推广期刊和研究机构的时事通讯与主要利益相关者分享,如国家或国际卫生当局、医疗保健专业人员和普通民众。