Department of Anesthesiology and Perioperative Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China.
Anesthesia Clinical Research Center, Xijing Hospital, Xi'an, Shaanxi, China.
BMJ Open. 2023 Aug 24;13(8):e072608. doi: 10.1136/bmjopen-2023-072608.
There is currently limited evidence addressing perioperative prognosis of surgical patients during COVID-19 pandemic; especially targeting on the Chinese population since the wave in 2022. Considering a distinct feature from the rest of the world demonstrated and the fast mutation and spread of the virus, evidence most relevant to China is urgently in need. The objective of this study is to seek for supporting evidence via evidence-based risk evaluations for postoperative complications to accumulate experience for coming infection waves.
This protocol proposes a multicentral, prospective, observational cohort study aiming to explore the link between SARS-CoV-2 infection and postoperative complications among surgical patients under general or regional anaesthesia between 16 January 2023 and 31 December 2023. A retrospective cohort covering the same period in 2019 is extracted for historic reference. Data are extracted from the health information system and anaesthesia information management system. The COVID-19 information is collected via an online survey. Missing values in weight or height will be imputed by each other with age and gender via multiple imputation. Other missing values will not be handled specially. Standard descriptive statistics will be reported followed by statistical modelling. Binomial regression with logit link is used for binary outcome. The time-to-event outcome is analysed using Cox regression with discharge from hospital further treated as a competing state. Hierarchical models will be assessed to account for temporal or central random effects. Temporal trends will be displayed with future expectations.
Ethical approval is obtained from the ethical committee in Xijing Hospital (No. KY20232002-C-1); approvals are expected for each participating institute. Verbal consent will be informed and obtained prior to online survey collection. Personal information remains confidential, and publications will be deidentified.
NCT05677815.
目前针对 COVID-19 大流行期间外科患者围手术期预后的证据有限；特别是针对 2022 年中国疫情高峰期的研究。考虑到与世界其他地区不同的特点，以及病毒的快速突变和传播，迫切需要最相关的中国证据。本研究旨在通过基于证据的术后并发症风险评估来寻求支持性证据，为未来的感染浪潮积累经验。
本方案提出了一项多中心、前瞻性、观察性队列研究，旨在探索 SARS-CoV-2 感染与接受全身或区域麻醉的外科患者术后并发症之间的联系，研究时间为 2023 年 1 月 16 日至 2023 年 12 月 31 日。同时提取同期 2019 年的回顾性队列作为历史参考。数据从健康信息系统和麻醉信息管理系统中提取。通过在线调查收集 COVID-19 信息。体重或身高的缺失值将通过年龄和性别相互插补，其他缺失值将不作特殊处理。将报告标准描述性统计数据，然后进行统计建模。二项式回归采用对数链接分析二项结局。采用 Cox 回归分析时间事件结局，将出院进一步视为竞争状态。将评估分层模型以考虑时间或中心随机效应。未来预期将显示时间趋势。
本研究已获得西京医院伦理委员会的批准（编号：KY20232002-C-1）；预计每个参与机构都将获得批准。将在在线调查收集前告知并获得口头同意。个人信息将保密，发表文章将进行去识别化处理。
NCT05677815。
