A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial).
A study protocol for a multicentre, prospective, before-and-after trial evaluating the feasibility of implementing targeted SEDation after initiation of mechanical ventilation in the emergency department (The ED-SED Pilot Trial).
复制标题
一项针对多中心，前瞻性的，前后试验的研究方案，评估了急诊科开始机械通气后实施靶向镇静的可行性（ED-SED PILOT试验）。
DOI：
10.1136/bmjopen-2020-041987
复制
发表时间：
2020-12-16
期刊：
影响因子：
2.9
通讯作者：
Avidan MS
中科院分区：
文献类型：
--
作者：
Fuller BM;Roberts BW;Mohr NM;Pappal RD;Stephens RJ;Yan Y;Carpenter C;Kollef MH;Avidan MS
镇静是接受机械通气患者管理的基础疗法，对结局有很大影响。早期镇静深度似乎特别有影响力，因为与轻度镇静相比，早期深度镇静与更差的结局相关。我们的研究小组发现，在急诊科（艾德）接受机械通气的患者通常暴露于深度镇静，而艾德镇静深度对重症监护室（ICU）护理和临床结局有影响。虽然对ICU患者进行了广泛的研究，但ED的数据相对较少。鉴于艾德镇静似乎具有影响，以及缺乏基于ED的镇静试验，将基于ED的镇静作为改善结局的一种手段进行研究是有意义的。这是一项多中心（n=3）前瞻性、前后对照的初步试验，旨在研究在ED插管后即刻实施靶向镇静的可行性。将纳入344例艾德接受机械通气的患者队列。可行性成果包括：（1）参与者招募;（2）深度镇静范围内里士满躁动-镇静量表（RASS）评分的比例;（3）床边艾德护士进行RASS测量的可靠性（一致性）;（4）不良事件。将使用χ2检验比较干预前后深度镇静测量的比例。将使用逻辑回归来比较前后差异，调整潜在的混杂因素。评估者间相关系数将用于评估研究团队成员和床旁艾德护士之间的配对观察结果，并描述RASS测量的可靠性。位于圣路易斯医学院的华盛顿大学人类研究保护办公室已经批准了这项研究。将通过出版经同行审查的手稿和在科学会议上介绍摘要来传播这项工作。ClinicalTrials.gov标识符NCT 04410783;预结果。
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 χ2 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.
登录
查看更多内容
影响因子：
8.8
作者：
Fuller BM;Ferguson IT;Mohr NM;Drewry AM;Palmer C;Wessman BT;Ablordeppey E;Keeperman J;Stephens RJ;Briscoe CC;Kolomiets AA;Hotchkiss RS;Kollef MH
通讯作者：
Kollef MH
DOI：
10.1186/cc8212
发表时间：
2009
期刊：
Critical care (London, England)
影响因子：
--
作者：
Jackson DL;Proudfoot CW;Cann KF;Walsh TS
通讯作者：
Walsh TS
影响因子：
3.6
作者：
Easter, Benjamin D.;Fischer, Christopher;Fisher, Jonathan
通讯作者：
Fisher, Jonathan
影响因子：
9.6
作者：
Fuller, Brian M.;Mohr, Nicholas M.;Kollef, Marin H.
通讯作者：
Kollef, Marin H.
影响因子：
8.8
作者：
Fuller, Brian M.;Roberts, Brian W.;Avidan, Michael S.
通讯作者：
Avidan, Michael S.