Appelboam Andrew, Reuben Adam, Mann Clifford, Lobban Trudie, Ewings Paul, Benger Jonathan, Vickery Jane, Barton Andrew, Gagg James
Department of Emergency Medicine, Royal Devon and Exeter Hospital NHS Foundation Trust, Exeter, Devon, UK.
BMJ Open. 2014 Mar 12;4(3):e004525. doi: 10.1136/bmjopen-2013-004525.
The Valsalva manoeuvre (VM) is a recommended first-line physical treatment for patients with re-entrant supraventricular tachycardia (SVT), but is often ineffective in standard practice. A failed VM is typically followed by treatment with intravenous adenosine, which patients often find unpleasant. VM effectiveness might be improved by a modification to posture which exaggerates the manoeuvre's vagal response and reduces the need for further emergency treatment.
This is a multicentre randomised controlled clinical trial in 10 UK emergency departments (EDs). It compares a standard VM with a modified VM incorporating leg elevation and a supine posture after a standardised strain in stable adult patients presenting to the ED with SVT. The primary outcome measure is return to sinus rhythm on a 12-lead ECG. Secondary outcome measures include the need for treatment with adenosine or other antiarrhythmic treatments and the time patients spend in the ED. We plan to recruit approximately 372 patients, with 80% power to demonstrate an absolute improvement in cardioversion rate of 12%. An improvement of this magnitude through the use of a modified VM would be of significant benefit to patients and healthcare providers, and justify a change to standard practice.
The study has been approved by the South West-Exeter Research Ethics Committee (REC reference 12/SW/0281). The trial will be published in an international peer reviewed journal. Study findings will be sent to the European and International resuscitation councils to inform future revisions of arrhythmia management guidelines.
The trial will also be disseminated at international conferences and to patients through the Arrhythmia Alliance, a patient support charity.
The study is registered with Current Controlled Trials (ISRCTN67937027) and has been adopted by the National Institute for Health Research (NIHR) Clinical Research Network.
瓦尔萨尔瓦动作（VM）是折返性室上性心动过速（SVT）患者推荐的一线物理治疗方法，但在标准实践中往往无效。VM失败后通常接着用静脉注射腺苷治疗，而患者通常觉得这种治疗令人不适。通过改变姿势可能会提高VM的有效性，这种姿势改变会增强该动作的迷走神经反应，并减少进一步进行紧急治疗的需求。
这是一项在英国10个急诊科进行的多中心随机对照临床试验。它将标准VM与改良VM进行比较，改良VM包括在急诊科因SVT前来就诊的稳定成年患者进行标准化用力后抬高腿部并采取仰卧姿势。主要结局指标是12导联心电图恢复窦性心律。次要结局指标包括使用腺苷或其他抗心律失常治疗的需求以及患者在急诊科的停留时间。我们计划招募约372名患者，检验效能为80%，以证明复律率绝对提高12%。通过使用改良VM实现这种程度的改善将对患者和医疗服务提供者有显著益处，并证明改变标准实践是合理的。
该研究已获得西南 - 埃克塞特研究伦理委员会批准（伦理审查委员会参考号12/SW/0281）。该试验将发表在国际同行评审期刊上。研究结果将发送给欧洲和国际复苏委员会，以为心律失常管理指南的未来修订提供参考。
该试验还将在国际会议上进行传播，并通过患者支持慈善机构心律失常联盟向患者传播。
该研究已在“当前受控试验”（ISRCTN67937027）注册，并已被英国国家卫生研究院（NIHR）临床研究网络采用。
