OBJECTIVES: 

Deep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial.

DESIGN: 

Pragmatic, multicenter (n = 3), prospective before-after pilot and feasibility trial.

SETTING: 

The ED and ICUs at three medical centers.

PATIENTS: 

Consecutive, adult mechanically ventilation ED patients.

INTERVENTIONS: 

An educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome).

MEASUREMENTS AND MAIN RESULTS: 

Sedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of –3 to –5 or a Sedation-Agitation Scale of 1–3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% (p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group (p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both.

CONCLUSIONS: 

This pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.

中文翻译：

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在机械通气急诊科患者中实施针对性 SED 的可行性：ED-SED 试点试验*

目标： 

急诊科 (ED) 中的深度镇静很常见，会增加ICU 中的深度镇静效果，并且与结果呈负相关。因此，限制急诊科深度镇静可能是改善预后的有效干预措施。然而，进行充分动力的基于 ED 的临床镇静试验的可行性尚不清楚。我们的目标是从以下方面评估试验的可行性：1) 招募，2) 方案实施和实践变更，以及 3) 安全性。评估以患者为中心的临床结果，以便更好地规划未来的大规模临床试验。

设计： 

务实、多中心（n = 3）、前瞻性前后试点和可行性试验。

环境： 

三个医疗中心的急诊室和重症监护室。

患者： 

连续接受机械通气的成人 ED 患者。

干预措施： 

一项教育举措，旨在可靠地记录急诊科镇静深度并减少深度镇静患者的比例（主要结果）。

测量和主要结果： 

记录急诊科和 ICU 前 48 小时内的镇静相关数据。深度镇静定义为 Richmond 躁动-镇静量表 –3 至 –5 或镇静–躁动量表 1-3。筛查了一千三百五十六名患者；最终人口为 415 人。干预组实现了较轻的急诊镇静，深度镇静的患者比例从 60.2% 降至 38.8%（p < 0.01）。不良事件没有令人担忧的趋势（即意外拔管、装置移除和意识到瘫痪）。干预组的死亡率为 10.0%，干预前组的死亡率为 20.4% ( p < 0.01)。与干预前相比，干预组的无呼吸机天数 [22.0 (9.0) vs 19.9 (10.6)] 和无 ICU 天数 [20.8 (8.7) vs 18.1 (10.4)] 更长，两者均 p < 0.05 。

结论： 

该试点试验证实了以急诊室为目标改善镇静实践并减少深度镇静的可行性。这些发现证明了针对基于 ED 的镇静剂进行适当动力的临床试验的合理性，以改善临床结果。