Department of Health Data Science, Yokohama City University, Yokohama, Japan.
Department of Health Data Science, Yokohama City University, Yokohama, Japan
BMJ Open. 2023 Jun 23;13(6):e069309. doi: 10.1136/bmjopen-2022-069309.
In general, caesarean sections are performed under spinal anaesthesia. Hypotension after spinal anaesthesia adversely affects both the mother and fetus. Although several studies have used pulse oximetry-derived indices, such as pulse perfusion index (PI) and Pleth variability index (PVI), to predict hypotension after spinal anaesthesia, the predictive ability of the PI and PVI remain controversial.
We prepared this protocol following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. We will conduct searches of MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Clinicaltrial.gov, European Union Clinical Trials Register (EU-CTR), WHO International Clinical Trials Registry Platform (ICTRP) and University Hospital Medical Information Network Clinical Trials Registry (UMIN) from inception until 8 October 2022. We will include retrospective and prospective observational studies and randomised controlled trials that evaluated the predictive ability of PI and PVI for hypotension after spinal anaesthesia for caesarean section, published in any language. We will exclude case reports, case series and animal studies. Two authors will independently scan and select eligible studies and perform data extraction and assessment of risk of bias. We will estimate predictive ability of PI and PVI as indices of hypotension after spinal anaesthesia for caesarean section using the Reitsma-type bivariate random-effects synthesis model and the hierarchical summary receiver operating characteristic curve. We will assess the quality of evidence using the Grading of Recommendation Assessment, Development and Evaluation approach.
Ethics approval is not required as the systematic review will use existing published data. The results will be submitted for publication in a peer-reviewed journal.
CRD42022362596.
一般来说,剖宫产术是在脊髓麻醉下进行的。脊髓麻醉后低血压会对母亲和胎儿都产生不利影响。尽管有几项研究使用脉搏血氧仪衍生指数,如脉搏灌注指数(PI)和脉搏变异指数(PVI)来预测脊髓麻醉后低血压,但 PI 和 PVI 的预测能力仍存在争议。
我们按照系统评价和荟萃分析报告标准制定了本方案。我们将从建库开始至 2022 年 10 月 8 日对 MEDLINE、Embase、Web of Science、Cochrane 对照试验中心注册库、Cochrane 系统评价数据库、Clinicaltrial.gov、欧盟临床试验注册中心(EU-CTR)、世界卫生组织国际临床试验注册平台(ICTRP)和大学医院医疗信息网络临床试验注册(UMIN)进行检索。我们将纳入评价 PI 和 PVI 对剖宫产脊髓麻醉后低血压预测能力的回顾性和前瞻性观察性研究和随机对照试验,发表语言不限。我们将排除病例报告、病例系列和动物研究。两名作者将独立扫描和选择合格的研究,并进行数据提取和偏倚风险评估。我们将使用 Reitsma 型双变量随机效应综合模型和分层综合受试者工作特征曲线来评估 PI 和 PVI 作为预测剖宫产脊髓麻醉后低血压的指标的预测能力。我们将使用推荐评估、制定与评价方法对证据质量进行评估。
由于系统评价将使用现有发表的数据,因此不需要伦理批准。结果将提交给同行评议的期刊发表。
PROSPERO 注册号:CRD42022362596。