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Investigating the efficacy of chest pressure for direct current cardioversion in atrial fibrillation: a randomised control trial protocol (Pressure-AF)
Open Heart Pub Date : 2021-09-01 , DOI: 10.1136/openhrt-2021-001739
David Ferreira 1, 2 , Philo Mikhail 3 , Michael McGee 2, 4 , Andrew Boyle 2, 5, 6 , Aaron Sverdlov 2, 5, 6 , Maged William 3 , Nicholas Jackson 5 , Malcolm Barlow 5 , James Leitch 5 , Nicholas Collins 2, 5, 6 , Thomas Ford 2, 3 , Bradley Wilsmore 5
Affiliation  

Introduction Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. Direct current cardioversion is commonly used to restore sinus rhythm in patients with AF. Chest pressure may improve cardioversion success through decreasing transthoracic impedance and increasing cardiac energy delivery. We aim to assess the efficacy and safety of routine chest pressure with direct current cardioversion for AF. Methods and analysis Multicentre, double blind (patient and outcome assessment), randomised clinical trial based in New South Wales, Australia. Patients will be randomised 1:1 to control and interventional arms. The control group will receive four sequential biphasic shocks of 150 J, 200 J, 360 J and 360 J with chest pressure on the last shock, until cardioversion success. The intervention group will receive the same shocks with chest pressure from the first defibrillation. Pads will be placed in an anteroposterior position. Success of cardioversion will be defined as sinus rhythm at 1 min after shock. The primary outcome will be total energy provided. Secondary outcomes will be success of first shock to achieve cardioversion, transthoracic impedance and sinus rhythm at post cardioversion ECG. Ethics and dissemination Ethics approval has been confirmed at all participating sites via the Research Ethics Governance Information System. The trial has been registered on the Australia New Zealand Clinical Trials Registry (ACTRN12620001028998). De-identified patient level data will be available to reputable researchers who provide sound analysis proposals. Data are available upon reasonable request. De-identified patient level data will be available to reputable researchers who provide sound analysis proposals.

中文翻译:

研究胸压对房颤直流电复律的疗效:随机对照试验方案 (Pressure-AF)

简介 心房颤动 (AF) 是世界范围内最常见的持续性心律失常。直流电复律通常用于恢复房颤患者的窦性心律。胸压可以通过降低经胸阻抗和增加心脏能量输送来提高心脏复律的成功率。我们的目标是评估常规胸压对 AF 进行直流电复律的有效性和安全性。方法和分析 位于澳大利亚新南威尔士的多中心、双盲(患者和结果评估)随机临床试验。患者将按 1:1 随机分配至对照组和介入组。对照组将接受 150 J、200 J、360 J 和 360 J 四个连续双相电击,最后一次电击胸压,直到复律成功。干预组将接受与第一次除颤产生的胸部压力相同的电击。垫将放置在前后位置。电复律成功定义为电击后 1 分钟出现窦性心律。主要结果将是提供的总能量。次要结果将是第一次电击成功实现复律、经胸阻抗和复律后心电图的窦性心律。伦理和传播 伦理批准已通过研究伦理治理信息系统在所有参与地点得到确认。该试验已在澳大利亚新西兰临床试验注册处注册(ACTRN12620001028998)。提供合理分析建议的信誉良好的研究人员将可以使用去标识化的患者级别数据。可应合理要求提供数据。
更新日期:2021-09-23
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