Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL, UK.
Scand J Trauma Resusc Emerg Med. 2010 Nov 5;18:58. doi: 10.1186/1757-7241-18-58.
Survival after out-of-hospital cardiac arrest is closely linked to the quality of CPR, but in real life, resuscitation during prehospital care and ambulance transport is often suboptimal. Mechanical chest compression devices deliver consistent chest compressions, are not prone to fatigue and could potentially overcome some of the limitations of manual chest compression. However, there is no high-quality evidence that they improve clinical outcomes, or that they are cost effective. The Prehospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) trial is a pragmatic cluster randomised study of the LUCAS-2 device in adult patients with non-traumatic out-of-hospital cardiac arrest.
METHODS/DESIGN: The primary objective of this trial is to evaluate the effect of chest compression using LUCAS-2 on mortality at 30 days post out-of-hospital cardiac arrest, compared with manual chest compression. Secondary objectives of the study are to evaluate the effects of LUCAS-2 on survival to 12 months, cognitive and quality of life outcomes and cost-effectiveness.
Ambulance service vehicles will be randomised to either manual compression (control) or LUCAS arms. Adult patients in out-of-hospital cardiac arrest, attended by a trial vehicle will be eligible for inclusion. Patients with traumatic cardiac arrest or who are pregnant will be excluded. The trial will recruit approximately 4000 patients from England, Wales and Scotland. A waiver of initial consent has been approved by the Research Ethics Committees. Consent will be sought from survivors for participation in the follow-up phase.
The trial will assess the clinical and cost effectiveness of the LUCAS-2 mechanical chest compression device.
The trial is registered on the International Standard Randomised Controlled Trial Number Registry (ISRCTN08233942).
院外心脏骤停后的存活率与 CPR 的质量密切相关，但在现实生活中，院前急救和救护车转运过程中的复苏往往并不理想。机械胸外按压设备能提供持续的胸外按压，不易疲劳，并且有可能克服手动胸外按压的一些局限性。然而，目前尚无高质量证据表明它们能改善临床结局，也没有证据表明它们具有成本效益。院前机械性胸外按压设备随机评估（PARAMEDIC）试验是一项关于成人非创伤性院外心脏骤停患者使用 LUCAS-2 设备的实用性集群随机研究。
方法/设计：本试验的主要目的是评估 LUCAS-2 胸外按压与手动胸外按压相比对院外心脏骤停后 30 天死亡率的影响。该研究的次要目标是评估 LUCAS-2 对 12 个月生存率、认知和生活质量结局以及成本效益的影响。
救护车将被随机分配到手动按压（对照组）或 LUCAS 组。试验车辆到场的院外心脏骤停的成年患者将有资格入组。创伤性心脏骤停或妊娠患者将被排除在外。该试验将从英格兰、威尔士和苏格兰招募约 4000 名患者。研究伦理委员会已批准了初始同意豁免。将向幸存者征求参与随访阶段的同意。
该试验将评估 LUCAS-2 机械胸外按压设备的临床和成本效益。
该试验在国际标准随机对照试验注册号（ISRCTN08233942）上注册。
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