Department of Neurology, Leiden University Medical Centre, Leiden, The Netherlands.
Department of Neurology, Academic Medical Centre, Amsterdam, The Netherlands.
BMJ Open. 2018 Jun 27;8(6):e020844. doi: 10.1136/bmjopen-2017-020844.
Time is the most crucial factor limiting efficacy of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT). The delay between alarming the Emergency Medical Services (EMS) dispatch office and IVT/IAT initiation, that is, the (TSD), depends on logistics and team effort. A promising method to reduce TSD is real-time audio-visual feedback to caregivers involved. With 'A Reduction in Time with Electronic Monitoring in Stroke' (ARTEMIS), we aim to investigate the effect of real-time audio-visual feedback on actual TSD to IVT/IAT to caregivers.
ARTEMIS is a multiregional, multicentre, randomised open end-point trial including patients ≥18 years considered IVT/IAT-eligible by the EMS dispatch office or on-site EMS personnel. Patients are electronically tracked and randomised for real-time audio-visual feedback on TSD to caregivers via premounted handhelds and tablets throughout the TSD trajectory. Primary outcome is TSD to IVT/IAT. Secondary outcomes comprise proportion of IVT/IAT-treated patients, symptomatic intracerebral haemorrhage, IVT/IAT-treated stroke mimics, clinical outcome after three months and cost-effectiveness. Separate analyses for IAT-patients with or without prior IVT, within or out of office hours and EMS region will be performed. With 75 IAT-patients and 225 IVT-patients in each arm, we will be able to demonstrate a 20 min difference in TSD to IAT and a 10 min difference in TSD to IVT (p=0.05 and power=0.8).
Study findings will be disseminated through peer-reviewed journals and (inter)national conference presentations.
NCT02808806; Pre-results.
时间是限制静脉溶栓（IVT）和动脉内取栓（IAT）疗效的最关键因素。从向紧急医疗服务（EMS）调度办公室报警到开始 IVT/IAT 的延迟时间，即转运时间差（TSD），取决于物流和团队合作。减少 TSD 的一种有前途的方法是为相关护理人员提供实时音频-视频反馈。通过“电子监控在卒中中的时间减少”（ARTEMIS）研究，我们旨在调查实时音频-视频反馈对护理人员实际 TSD 至 IVT/IAT 的影响。
ARTEMIS 是一项多区域、多中心、随机开放终点试验，纳入了被 EMS 调度办公室或现场 EMS 人员认为符合 IVT/IAT 标准的≥18 岁患者。患者通过电子追踪并随机接受 TSD 至护理人员的实时音频-视频反馈，通过预安装的手持设备和平板电脑在整个 TSD 过程中进行。主要结局是 TSD 至 IVT/IAT。次要结局包括接受 IVT/IAT 治疗的患者比例、症状性颅内出血、IVT/IAT 治疗的卒中模拟病例、三个月后的临床结局和成本效益。将对 IAT 患者进行单独分析，包括有或没有先前 IVT 的患者、在办公时间内或外的患者以及 EMS 区域的患者。在每个手臂中，将有 75 名 IAT 患者和 225 名 IVT 患者，我们将能够证明 IAT 的 TSD 差异为 20 分钟，IVT 的 TSD 差异为 10 分钟（p=0.05，效能=0.8）。
研究结果将通过同行评议的期刊和（国际）会议报告进行传播。
NCT02808806；预结果。
