The Feasibility of Implementing Light Sedation after Initiation of Mechanical Ventilation in the Emergency Department: the ED-SED Pilot Trial

项目摘要/摘要 在美国，每年约有25万名患者在紧急情况下需要机械通风 超过30%的人会死亡。大多数幸存者经历了严重的长期残疾。 包括认知功能减退、心理功能障碍和长期康复。最近的数据表明， 接触深度镇静(即因过量服用镇静剂而失去意识或昏迷) 机械通风的启动与更长的机械通风持续时间、住院时间、 和死亡率。急诊室提供机械通风时，深度镇静是非常常见的； 然而，还没有临床研究测试是否在插管后立即进行靶向性光镇静。 艾德改善了结果。我们的假设是，在机械刺激开始后，以轻度镇静深度为目标 急诊室的通风与改善临床结果有关，包括减少机械治疗的时间 通风。为了验证这一假设，我们的团队将利用我们在临床启动方面的丰富经验。 在急诊室的研究和继续这些干预方案进入重症监护病房(ICU)，并将 建议未来多中心、阶梯楔形、整群随机试验。科学文献和我们的 初步数据为进行大规模临床试验提供了理论基础。 然而，目前有几个空白阻碍了继续进行。推行以教育为本的目标的可行性- 定向镇静方案在以下方面尚不清楚：1)招募；2)实现目标镇静的有效性；3) 急诊室常规护理期间镇静测量的可靠性；4)不良事件；5)障碍 实施。因此，这项建议是针对多中心(n=3)的前瞻性前后方案 一项针对插管后轻度镇静的方案可行性的实施研究 344例机械通气成人ED患者。这些数据将得到定性评估的补充 实施的障碍(对护士和医生的调查)。通过这个预备性试点的目标 通过研究，我们将获得必要和充分的数据，并展示出明确的组织结构， 对完成全面的临床试验至关重要。这个项目有可能彻底改变临床 实施早期镇静管理，提高急性脑出血患者的生存和生活质量 呼吸衰竭。考虑到机械通风的边缘经历的死亡和残疾的程度 对于患者来说，即使是轻微的改善也会带来重大的公共健康好处。

PROJECT SUMMARY/ABSTRACT Annually in the United States, approximately 250,000 patients require mechanical ventilation in the emergency department (ED) and over 30% will die. The majority of survivors experience crippling long-term disability including cognitive decline, psychological dysfunction, and lengthy rehabilitation. Recent data suggest that exposure to deep sedation (i.e. unconsciousness or coma due to excessive sedative administration) after the initiation of mechanical ventilation is associated with greater mechanical ventilation duration, lengths of stay, and mortality. Deep sedation is extremely common while mechanical ventilation is provided in the ED; however, no clinical study has tested if targeting light sedation in the immediate post-intubation period in the ED improves outcome. Our hypothesis is that targeting a light sedation depth after the initiation of mechanical ventilation in the ED is associated with improved clinical outcomes, including a reduced duration of mechanical ventilation. To test this hypothesis, our team will capitalize on our extensive experience with initiating clinical studies in the ED and continuing these intervention protocols into the intensive care unit (ICU), and will propose a future multi-center, stepped-wedge, cluster randomized trial. The scientific literature and our preliminary data provide the rationale for conducting a large-scale clinical trial. However, several gaps currently prohibit proceeding. The feasibility of implementing an ED-based goal- oriented sedation protocol is unknown in terms of: 1) recruitment; 2) efficacy in achieving target sedation; 3) reliability of sedation measurements during routine care in the ED; 4) adverse events; and 5) barriers to implementation. Therefore this proposal is for a multicenter (n= 3) prospective before-and-after protocol implementation study examining the feasibility of a protocol which targets light sedation after intubation among 344 mechanically ventilated adult ED patients. These data will be supplemented with a qualitative assessment of barriers to implementation (survey of nurses and physicians). Through the aims of this preparatory pilot study, we will acquire the necessary and sufficient data, and demonstrate a clear organizational structure, critical to complete the full-scale clinical trial. This project has the potential to completely change the clinical practice of early sedation management, and improve survival and quality of life in patients suffering from acute respiratory failure. Given the magnitude of death and disability experienced by mechanically ventilated ED patients, even modest improvements would provide a major public health benefit.