Department of Anesthesiology, Division of Critical Care, Division of Emergency Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
Departments of Emergency Medicine and Anesthesiology, Division of Critical Care, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.
BMJ Open. 2018 Oct 21;8(10):e023423. doi: 10.1136/bmjopen-2018-023423.
In mechanically ventilated patients, sedation strategies are a major determinant of outcome. The emergency department (ED) is the earliest exposure to mechanical ventilation for hundreds of thousands of patients annually in the USA. The one retrospective study that exists regarding ED sedation for mechanically ventilated patients showed a strong association between deep sedation in the ED and worse clinical outcomes. This finding suggests that the ED may be an optimal location to study the impact of early sedation on outcome, yet a lack of prospective studies represents a knowledge gap in this arena. This protocol describes a prospective observational study aimed at further characterising ED sedation practices and assessing the relationship between ED sedation and clinical outcomes. An association between ED sedation and clinical outcomes across multiple sites would suggest the need for changes in the current sedation strategies used in the ED, and provide evidence for future interventional studies in this field.
This is a multicentre, prospective cohort study testing the hypothesis that deep sedation in the ED is associated with worse clinical outcomes. A cohort of over 300 mechanically ventilated ED patients will be included. The primary outcome is ventilator-free days, and secondary outcomes include hospital mortality, incidence of acute brain dysfunction and lengths of stay. Multivariable linear regression will test the hypothesis that deep sedation in the ED is associated with a decrease in ventilator-free days.
Approval of the study by the Institutional Review Board (IRB) at each participating site has been obtained prior to data collection on the first patient. This work will be disseminated by publication of peer-reviewed manuscripts, presentation in abstract form at scientific meetings and data sharing with other investigators through academically established means.
在机械通气患者中，镇静策略是决定预后的主要因素。急诊科（ED）是美国每年数十万接受机械通气患者最早接触的科室。目前唯一一项关于 ED 机械通气患者镇静的回顾性研究表明，ED 深度镇静与更差的临床结局之间存在很强的关联。这一发现表明，ED 可能是研究早期镇静对结局影响的理想场所，但缺乏前瞻性研究是该领域的一个知识空白。本方案描述了一项前瞻性观察性研究，旨在进一步描述 ED 镇静实践，并评估 ED 镇静与临床结局之间的关系。ED 镇静与临床结局之间的关联表明，需要改变目前 ED 中使用的镇静策略，并为该领域的未来干预性研究提供证据。
这是一项多中心前瞻性队列研究，旨在检验 ED 深度镇静与更差临床结局相关的假设。将纳入超过 300 例机械通气的 ED 患者。主要结局是无呼吸机天数，次要结局包括医院死亡率、急性脑功能障碍发生率和住院时间。多变量线性回归将检验 ED 深度镇静与无呼吸机天数减少相关的假设。
在对第一个患者进行数据收集之前，每个参与地点的机构审查委员会（IRB）已批准该研究。这项工作将通过发表同行评议的论文、在科学会议上以摘要形式展示以及通过学术上确立的方式与其他研究人员共享数据来传播。
