SmartCPR 试验:基于波形的自动体外除颤 (AED) 算法对院外心室颤动生存率的分析 (SmartCPR)
基于波形的自动体外除颤算法用于治疗心室颤动的国际、随机、对照院前试验
研究概览
详细说明
长期以来,电击(称为除颤)一直被认为是院外心脏骤停后“生存链”中的关键“环节”之一。 对于存在心室颤动 (VF) 的患者尤其如此,这是一种心脏下部(心室)持续但不协调的放电状态,并且能够在这些患者到达医院之前对其进行除颤治疗医院仍然是该组代表最有可能在院外心脏骤停中幸存下来的患者的原因之一。
尽管这项技术已在院前环境中成功应用 40 多年,但长期以来“立即除颤”是所有患者的最佳治疗方法的信念现在受到质疑。
在华盛顿州西雅图和挪威奥斯陆等地进行的研究之后,人们认识到一些患者(特别是那些在 EMS 到达之前心脏骤停 4-5 分钟的患者)实际上可能会受益于提前一段时间的心肺复苏术除颤(“延迟除颤”)。 这与 VF 发作后心脏内发生的变化有关,甚至与心脏内细胞水平的变化有关。 VF 几分钟后,心脏内的细胞已被剥夺和耗尽氧气和其他含能量分子,并且已经积累了其他物质,例如酸和钾。 通过在除颤之前提供心肺复苏,据认为可以为患者的心脏提供足够的氧气和其他含能分子,从而使心脏更有可能对除颤作出有利的反应。
然而,这并不一定适用于所有 VF 患者。 来自目睹了虚脱和心脏骤停并且能够非常迅速地为其提供除颤的患者的其他数据(即 那些在机场、飞机和赌场中的人)与那些长期被捕的病人相比,表现出非常高的存活率。 这表明有些患者最好接受立即除颤治疗,有些患者接受“延迟除颤”治疗。
现代紧急医疗服务 (EMS) 系统的问题包括确定 VF 何时开始、旁观者 CPR 的影响、心脏骤停时患者的整体状况以及从 911 呼叫到急救人员到达的时间间隔EMS 提供者(EMT 和护理人员)在患者身边。
通过选择为所有患者提供即时除颤,希望使那些最有可能对除颤做出反应并存活下来的患者受益,EMS 系统将同时选择为那些可能受益于“延迟除颤。” 相反,选择为所有患者提供“延迟除颤”可能会适当地治疗任何 EMS 系统中较大比例的 VF 患者,但它可能会延迟那些最有可能存活下来的患者(将受益于立即除颤)。
涉及 VF 波形(人眼无法计算的东西)的数学特性的研究导致了计算机算法的发展,这些算法可以根据计算出的 VF 数学“分数”预测患者是否可能做出更多反应有利于立即除颤或延迟除颤。 因此,这种技术似乎能够向每位患者推荐最适合其个体情况的治疗,并且随之而来的是,这种个体化治疗可能会提高 VF 心脏骤停的总体生存率。
本研究旨在检验这种技术对向纽约州纽约市和英国伦敦的 EMS 提供商就诊的 VF 患者的影响。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 初始治疗包括应用研究 AED
- 完整的初始波形分析
- 目前的节律是心室颤动
- 心脏病因停止
排除标准:
- 非心脏病因的停滞
- 使用非研究用除颤器进行初始治疗
- 缺少 AED 数据
- 年龄 <18(仅限伦敦)
- 因 DNR 命令/决定而终止复苏
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:标准复苏
该组中的患者将接受标准复苏治疗,包括对所有 VF 患者进行即时除颤电击。
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该组中的患者将接受立即除颤电击以及其他标准复苏措施。
其他名称:
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实验性的:智能心肺复苏术
除了第一次 AED 分析将使用基于波形的算法来为每位患者推荐立即除颤或延迟除颤外,该组中的患者将接受标准复苏治疗。
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除了第一次 AED 分析将使用基于波形的算法来为每位患者推荐立即除颤或延迟除颤外,该组中的患者将接受标准复苏治疗。
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有源比较器:延迟除颤
仅在纽约市,所有最初未接受研究人员治疗的患者将接受其他地区标准的复苏 - 延迟除颤。
也正在收集有关该人群的数据,从而为比较目的提供队列人群。
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仅在纽约市,所有最初未接受研究人员治疗的患者将接受其他地区标准的复苏 - 延迟除颤。
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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出院存活率
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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次要结果测量
结果测量 |
大体时间 |
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入院生存
大体时间:被捕后数小时内
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被捕后数小时内
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院前恢复自主循环 (ROSC)
大体时间:可变(取决于 EMS 联系时间)
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可变(取决于 EMS 联系时间)
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幸存者的神经系统状况
大体时间:变量(出院时测量)
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变量(出院时测量)
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与纽约市“延迟除颤”队列相比的存活率(定义为 ROSC、入院存活率和出院存活率)
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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CPR间期对VF波形特征的影响
大体时间:心肺复苏间隔后立即
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心肺复苏间隔后立即
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AED 算法和 VF 特征在 EMS 目击逮捕中的效用
大体时间:变量(一些即时数据,一些取决于入院和出院所需的时间间隔)
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变量(一些即时数据,一些取决于入院和出院所需的时间间隔)
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这种 AED 技术的实用性和 VF 特征在儿科患者中的应用
大体时间:变量(一些即时数据,一些取决于入院和出院所需的时间间隔)
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变量(一些即时数据,一些取决于入院和出院所需的时间间隔)
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旁观者 CPR 对 VF 波形特征的影响
大体时间:立即(从逮捕期间的数据中获取)
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立即(从逮捕期间的数据中获取)
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EMS 响应时间与 VF 波形特性的比较
大体时间:立即(在 EMS 响应和逮捕期间获得的数据)
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立即(在 EMS 响应和逮捕期间获得的数据)
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院外心脏骤停患者难以管理气道的频率
大体时间:立即(在逮捕时测量)
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立即(在逮捕时测量)
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患者种族对提供旁观者 CPR、VF 波形特征和生存率的影响
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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呈现和间隔波形二氧化碳图读数与生存之间的关系
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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院外心脏骤停患者转院后未能存活出院的器官捐献频率
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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继发性 VF 患者的波形特征(最初出现心律停搏或无脉性电活动)
大体时间:立即(来自逮捕期间收集的数据)
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立即(来自逮捕期间收集的数据)
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在心脏骤停期间使用骨内通路的患者的描述和结果
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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Utstein 两个城市(伦敦和纽约)的比较
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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旁观者 CPR 对生存的影响作为响应时间的函数
大体时间:可变(取决于入院和出院所需的时间间隔)
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可变(取决于入院和出院所需的时间间隔)
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纽约市环境小颗粒 (PM2.5) 污染与心脏骤停指数之间的关联
大体时间:由模型确定
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由模型确定
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合作者和调查者
调查人员
- 首席研究员:John P Freese, MD、New York City Fire Department
- 研究主任:Bradley J Kaufman, MD, MPH、New York City Fire Department
- 研究主任:Rachael Donohoe, PhD、London Ambulance Service
- 研究主任:Dawn Jorgenson, PhD、Philips Medical Systems
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