1 Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany.
2 Department for Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Int J Stroke. 2017 Aug;12(6):653-658. doi: 10.1177/1747493017700152. Epub 2017 Mar 22.
Rationale Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves the prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of better functional outcome compared to usual care is still lacking. Aim To prove better functional outcomes after deployment of the Stroke Emergency Mobile compared to regular ambulances. Sample size estimates A sample size of 686 patients will be required in each arm (Stroke Emergency Mobile group vs. regular care) to detect a difference regarding the primary outcome with 80% power at a two-sided significance level of 0.05. Methods and design This is a pragmatic, prospective study with blinded outcome assessment. Primary outcome will be functional status as defined by modified Rankin Scale score three months after the incident event. We will include cerebral ischemia patients within a predefined catchment area in Berlin, Germany. The study population consists of patients who might be candidates for acute recanalizing treatments, with onset-to-alarm time ≤4 h, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to the qualifying incident. About 45% of Stroke Emergency Mobile dispatches are expected to be handled by regular ambulances, since Stroke Emergency Mobile will be already in operation creating the control group. Primary outcome Functional outcome after three months measured by the modified Rankin Scale over the entire range. Discussion The results will inform decision makers on the effectiveness of Stroke Emergency Mobile.
背景 在专门的救护车上进行院前卒中护理可提高溶栓率，缩短报警至治疗时间，并改善院前分诊。初步分析表明其具有成本效益。然而，与常规护理相比，其在改善功能预后方面的科学证据仍不足。目的 证明与常规救护车相比，卒中急救车的应用可改善患者的功能预后。样本量估计 每组（卒中急救车组与常规护理组）需要 686 例患者，才能在双侧检验水准为 0.05 时，以 80%的效能检测出主要结局的差异。方法和设计 这是一项实用、前瞻性、结局评估设盲的研究。主要结局将通过发病 3 个月后的改良 Rankin 量表评分来定义。我们将在德国柏林的一个预先划定的集水区内纳入脑缺血患者。研究人群包括可能适合进行急性再通治疗的患者，其发病至报警时间≤4 小时，救护车到达时症状未缓解，且在符合条件的发病事件之前能够无需辅助行走。预计卒中急救车的约 45%的出动会由常规救护车处理，因为卒中急救车已经在运行，可作为对照组。主要结局 整个改良 Rankin 量表评分范围内发病 3 个月后的功能结局。讨论 研究结果将为决策者提供有关卒中急救车有效性的信息。
