Department of Anesthesiology, Division of Critical Care, Department of Emergency Medicine, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA
Department of Emergency Medicine, Cooper University Hospital, One Cooper Plaza, Camden, New Jersey, USA.
BMJ Open. 2020 Dec 16;10(12):e041987. doi: 10.1136/bmjopen-2020-041987.
Sedation is a cornerstone therapy in the management of patients receiving mechanical ventilation and is highly influential on outcome. Early sedation depth appears especially influential, as early deep sedation is associated with worse outcome when compared with light sedation. Our research group has shown that patients receiving mechanical ventilation in the emergency department (ED) are exposed to deep sedation commonly, and ED sedation depth is impactful on intensive care unit (ICU) care and clinical outcomes. While extensive investigation has occurred for patients in the ICU, comparatively little data exist from the ED. Given the influence that ED sedation seems to carry, as well as a lack of ED-based sedation trials, there is significant rationale to investigate ED-based sedation as a means to improve outcome.
This is a multicentre (n=3) prospective, before-and-after pilot trial examining the feasibility of implementing targeted sedation in the immediate postintubation period in the ED. A cohort of 344 patients receiving mechanical ventilation in ED will be included. Feasibility outcomes include: (1) participant recruitment; (2) proportion of Richmond Agitation-Sedation Scale (RASS) scores in the deep sedation range; (3) reliability (agreement) of RASS measurements performed by bedside ED nurses; and (4) adverse events. The proportion of deep sedation measurements before and after the intervention will be compared using the χ test. Logistic regression will be used to compare before-and-after differences, adjusting for potential confounders. The inter-rater correlation coefficient will be used to assess paired observations between a study team member and bedside ED nurses, and to describe reliability of RASS measurements.
The Human Research Protection Office at Washington University in St. Louis School of Medicine has approved the study. The publication of peer-reviewed manuscripts and the presentation of abstracts at scientific meetings will be used to disseminate the work.
ClinicalTrials.gov identifier NCT04410783; Pre-results.
镇静是机械通气患者管理的基石疗法，对结果有很大影响。早期镇静深度似乎尤其有影响，因为与轻度镇静相比，早期深度镇静与更差的结果相关。我们的研究小组已经表明，在急诊科（ED）接受机械通气的患者通常会接受深度镇静，ED 镇静深度对重症监护病房（ICU）护理和临床结果有影响。虽然对 ICU 患者进行了广泛的调查，但 ED 数据相对较少。鉴于 ED 镇静似乎具有的影响，以及缺乏基于 ED 的镇静试验，因此有充分的理由将基于 ED 的镇静作为改善结果的一种手段进行研究。
这是一项多中心（n=3）前瞻性、前后对照试验，研究了在 ED 中即刻插管后实施目标镇静的可行性。将纳入 344 名在 ED 接受机械通气的患者。可行性结果包括：（1）参与者招募；（2）Richmond 躁动-镇静量表（RASS）评分处于深度镇静范围的比例；（3）床边 ED 护士进行的 RASS 测量的可靠性（一致性）；（4）不良事件。干预前后深度镇静测量的比例将使用 χ 检验进行比较。Logistic 回归将用于比较前后差异，调整潜在的混杂因素。组内相关系数将用于评估研究小组成员与床边 ED 护士之间的配对观察，并描述 RASS 测量的可靠性。
华盛顿大学圣路易斯医学院人类研究保护办公室已批准该研究。将通过发表同行评议的论文和在科学会议上提交摘要来传播研究成果。
ClinicalTrials.gov 标识符 NCT04410783；预结果。
