背景:血管内血栓切除术(ET),如果可能的话,结合静脉溶栓,对于已确认前大血管闭塞(aLVO)的卒中患者,是一种有效的治疗选择。然而,ET主要限于综合性卒中中心(CSCs),导致远程的ET容量不足,人口稀少的地区。大多数中风网络使用“滴水和船”或“母船”策略,导致ET延迟或静脉溶栓,分别。
目的:本研究方案介绍了Leitstellen-BasierteErkennungvonSchlaganfall-PatientenfürineThrombektomieunddaraufhinabgestimementteOptimierungderRettungskette(LESTOR)策略,旨在优化卒中生存链的临床前部分,以改善疑似aLVO卒中患者的临床结局。这涉及使用基于电话的aLVO查询来改进用于识别急性aLVO中风患者的调度策略。这包括派遣急诊医生和紧急医疗服务(EMS)到城市紧急地点,以及向偏远地区派遣直升机EMS。如果在紧急现场进行结构化检查期间,在标准化的aLVO评分评估后识别出高度可疑的aLVO,应优先考虑及时运输到CSC。
方法:LESTOR研究是一项对照研究,实施LESTOR策略的非随机研究,用阶梯式楔形,德国西南部6个地区的集群试验设计。在一个跨专业的,迭代方法,供调度员使用的aLVO查询或调度协议,随后是一个协调的aLVO考试分数,供EMS使用,正在开发中,评估,并在模拟研究中进行了预测。在对所有参与的医疗保健专业人员进行相应的最终aLVO查询的培训之后,LESTOR战略正在逐步实施。否则,对照组和干预组的患者都会接受常规的中风护理。主要结果是接受血管内治疗的中风患者在90天的改良Rankin量表。我们将使用广义线性混合模型进行数据分析。这项研究伴随着成本效益分析和定性过程评估。
结果:本文描述并讨论了这种受控的协议,非随机LESTOR研究。注册于2023年6月完成。数据分析正在进行中,第一批结果预计将于2024年提交发布。该项目于2020年4月开始,将于2024年2月结束。
结论:我们预计干预措施将改善aLVO卒中患者的临床结局,特别是在CSC的集水区之外。附带的过程评估和成本效益分析的结果将提供对实施过程的进一步见解,并可以更好地解释结果。
背景:德国临床试验注册DRKS00022152;https://drks。de/search/de/trial/DRKS00022152.
■DERR1-10.2196/51683。
BACKGROUND: Endovascular thrombectomy (ET), combined with intravenous thrombolysis if possible, is an effective treatment option for patients with stroke who have confirmed anterior large vessel occlusion (aLVO). However, ET is mainly limited to comprehensive stroke centers (CSCs), resulting in a lack of ET capacity in remote, sparsely populated areas. Most stroke networks use the \"Drip and Ship\" or \"Mothership\" strategy, resulting in either delayed ET or intravenous thrombolysis, respectively.
OBJECTIVE: This study protocol introduces the Leitstellen-Basierte Erkennung von Schlaganfall-Patienten für eine Thrombektomie und daraufhin abgestimmte Optimierung der Rettungskette (LESTOR) strategy, developed to optimize the preclinical part of the stroke chain of survival to improve the clinical outcome of patients with suspected aLVO stroke. This involves refining the dispatch strategy for identifying patients with acute aLVO stroke using a phone-based aLVO query. This includes dispatching emergency physicians and emergency medical services (EMS) to urban emergency sites, as well as dispatching helicopter EMS to remote areas. If a highly suspected aLVO is identified after a standardized aLVO score evaluation during a structured examination at the emergency scene, prompt transport to a CSC should be prioritized.
METHODS: The LESTOR
study is a controlled, nonrandomized
study implementing the LESTOR strategy, with a stepped-wedge, cluster
trial design in 6 districts in southwest Germany. In an interprofessional, iterative approach, an aLVO query or dispatch protocol intended for use by dispatchers, followed by a coordinated aLVO examination score for use by EMS, is being developed, evaluated, and pretested in a simulation
study. After the training of all participating health care professionals with the corresponding final aLVO query, the LESTOR strategy is being implemented stepwise. Patients otherwise receive usual stroke care in both the control and intervention groups. The primary outcome is the modified Rankin Scale at 90 days in patients with stroke receiving endovascular treatment. We will use a generalized linear mixed model for data analysis. This
study is accompanied by a cost-effectiveness analysis and a qualitative process evaluation.
RESULTS: This paper describes and discusses the protocol for this controlled, nonrandomized LESTOR study. Enrollment was completed in June 2023. Data analysis is ongoing and the first results are expected to be submitted for publication in 2024. The project started in April 2020 and will end in February 2024.
CONCLUSIONS: We expect that the intervention will improve the clinical outcome of patients with aLVO stroke, especially outside the catchment areas of CSCs. The results of the accompanying process evaluation and the cost-effectiveness analysis will provide further insights into the implementation process and allow for a better interpretation of the results.
BACKGROUND: German Clinical Trials Register DRKS00022152; https://drks.de/search/de/
trial/DRKS00022152.
UNASSIGNED: DERR1-10.2196/51683.