首页> 外文OA文献 >Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study
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Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Care Versus Standard Care for Patients Presenting to the Emergency Department with Palpitations and Pre-syncope: The IPED (Investigation of Palpitations in the ED) study

机译:基于智能手机的事件记录器的多中心随机对照试验与标准护理与标准护理,与心悸和晕厥患者展示给急诊部门:IPED(ED在艾德心悸的调查)研究

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摘要

Background: Patients with palpitations and pre-syncope commonly present to Emergency Departments (EDs) but underlying rhythm diagnosis is often not possible during the initial presentation. This trial compares the symptomatic rhythm detection rate of a smartphone-based event recorder (AliveCor) alongside standard care versus standard care alone, for participants presenting to the ED with palpitations and pre-syncope with no obvious cause evident at initial consultation. Methods: Multi-centre open label, randomised controlled trial. Participants ≥16 years old presenting to 10 UK hospital EDs were included. Participants were randomised to either (a) intervention group; standard care plus the use of a smartphone-based event recorder or (b) control group; standard care alone. Primary endpoint was symptomatic rhythm detection rate at 90 days. Trial registration number NCT02783898 (ClinicalTrials.gov). Findings: Two hundred forty-three participants were recruited over an 18-month period. A symptomatic rhythm was detected at 90 days in 69 (n = 124; 55.6%; 95% CI 46.9–64.4%) participants in the intervention group versus 11 (n = 116; 9.5%; 95% CI 4.2–14.8) in the control group (RR 5.9, 95% CI 3.3–10.5; p < 0.0001). Mean time to symptomatic rhythm detection in the intervention group was 9.5 days (SD 16.1, range 0–83) versus 42.9 days (SD 16.0, range 12–66; p < 0.0001) in the control group. The commonest symptomatic rhythms detected were sinus rhythm, sinus tachycardia and ectopic beats. A symptomatic cardiac arrhythmia was detected at 90 days in 11 (n = 124; 8.9%; 95% CI 3.9–13.9%) participants in the intervention group versus 1 (n = 116; 0.9%; 95% CI 0.0–2.5%) in the control group (RR 10.3, 95% CI 1.3–78.5; p = 0.006). Interpretation: Use of a smartphone-based event recorder increased the number of patients in whom an ECG was captured during symptoms over five-fold to more than 55% at 90 days. This safe, non-invasive and easy to use device should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope. Funding: This study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and British Heart Foundation (BHF) which included funding for purchasing the devices. MR was supported by an NHS Research Scotland Career Researcher Clinician award. Keywords: Ambulatory electrocardiography monitoring, Cardiac arrhythmias, Palpitations, Pre-syncope
机译:背景:伴随着急诊部门(EDS)的心悸和术前患者,但在初始介绍期间通常不可能潜在的节奏诊断。该试验比较了智能手机的事件记录仪(AliveCor)的症状节律检测率,与标准关怀相比,仅适用于与心悸和预晕染术的参与者,在初步咨询中没有明显的原因明显显而易见。方法:多中心开放标签,随机对照试验。参与者≥16年历史较大的旧式陈旧的医院EDS。参与者被随机分为(a)干预组;标准护理加上使用基于智能手机的事件记录器或(B)控制组;单独保养。主要终点是90天的症状节奏检测率。试用登记号码NCT02783898(ClinicalTrials.gov)。调查结果:在18个月的时间内招募了两百四十三位参与者。在69日(n = 124; 55.6%; 55.6%; 95%CI 46.9-64.4%)中检测到症状节律(n = 124; 95%CI 46.9-64.4%)参与者在11(n = 116; 9.5%; 95%ci 4.2-14.8)中对照组(RR 5.9,95%CI 3.3-10.5; P <0.0001)。在对照组中,介入组的平均症状节律检测为9.5天(SD 16.1,范围0-83),对照组中的42.9天(SD 16.0,范围12-66; P <0.0001)。检测到的最常见的症状节律是鼻窦节奏,窦性心动过速和异位搏动。在90日内在11(n = 124; 8.9%; 8.9%; 95%CI 3.9-13.9%)中检测到症状心律失常,在干预组的参与者与1(n = 116; 0.9%; 95%CI 0.0-2.5%)在对照组(RR 10.3,95%CI 1.3-78.5; p = 0.006)。解释:使用基于智能手机的事件记录仪增加了在90天的症状期间捕获ECG捕获的患者的数量。这种安全,无侵入性和易于使用的设备应被视为持续患者急性心悸或预先晕厥的患者的一部分。资金:本研究由胸部,心脏和中风苏格兰(CHSS)和英国心脏基金会(BHF)的研究奖资助,其中包括购买设备的资金。先生由NHS研究苏格兰职业研究员临床医生奖得到支持。关键词:动态心电图监测,心律失常,心悸,术前

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