Robinson Maria J, Taylor Jodi, Brett Stephen J, Nolan Jerry P, Thomas Matthew, Reeves Barnaby C, Rogers Chris A, Voss Sarah, Clout Madeleine, Benger Jonathan R
South Western Ambulance Service NHS Foundation Trust, Exeter, UK.
Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, UK.
Trials. 2019 Feb 8;20(1):108. doi: 10.1186/s13063-019-3203-0.
The research study titled "Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out-of-hospital cardiac arrest (AIRWAYS-2)" is a large-scale study being run in the English emergency medical (ambulance) services (EMS). It compares two airway management strategies (tracheal intubation and the i-gel) in out-of-hospital cardiac arrest. We describe the methods used to minimise bias and the challenges associated with the set-up, enrolment, and follow-up that were addressed.
AIRWAYS-2 enrols adults without capacity when there is no opportunity to seek prior consent and when the intervention must be delivered immediately. We therefore adopted a cluster randomised design where the unit of randomisation is the individual EMS provider (paramedic). However, because paramedics could not be blinded to the intervention, it was necessary to automatically enrol all eligible patients in the study to avoid bias. Effective implementation required engagement with four large EMS and 95 receiving hospitals. Very high levels of data capture were required to ensure study integrity, and this necessitated collaborative working across multiple organisations. We sought to manage these processes by using a large and comprehensive electronic study database, implementing efficient trial procedures and comprehensive training.
Successful implementation of the study design was facilitated by the approaches used. The necessary regulatory and ethical approvals to conduct the study were secured, and benefited from strong patient and public involvement. Early and continued consultation with decision makers within the four participating EMS resulted in a coordinated approach to study set-up. All receiving hospitals gave approval and agreed to collect data. A comprehensive database and programme of training and support were implemented. More than 1500 paramedics have been recruited to the study, and patient enrolment and follow-up has proceeded as planned.
Care provided by EMS needs to be based on evidence. Although participants may be experiencing life-threatening emergencies, high-quality pre-hospital research is possible in well-designed and well-managed studies. The approaches described here can be used to support successful research that will lead to improved treatment and outcomes in similar patient groups.
ISRCTN08256118 . Registered on 22 July 2014.
名为“院外心脏骤停初始气道管理中i-gel声门上气道装置与气管插管的临床及成本效益的整群随机试验（AIRWAYS-2）”的研究是一项在英国紧急医疗（救护车）服务（EMS）中开展的大规模研究。该研究比较了院外心脏骤停中的两种气道管理策略（气管插管和i-gel）。我们描述了用于尽量减少偏倚的方法以及在设置、入组和随访过程中所面临并解决的挑战。
当没有机会寻求事先同意且干预必须立即实施时，AIRWAYS-2纳入无行为能力的成年人。因此，我们采用了整群随机设计，随机化单位是个体EMS提供者（护理人员）。然而，由于护理人员无法对干预措施设盲，有必要自动将所有符合条件的患者纳入研究以避免偏倚。有效实施需要与四家大型EMS和95家接收医院合作。需要非常高水平的数据采集以确保研究的完整性，这就需要多个组织之间的协作。我们试图通过使用一个大型且全面的电子研究数据库、实施高效的试验程序和全面的培训来管理这些过程。
所采用的方法促进了研究设计的成功实施。获得了开展该研究所需的必要监管和伦理批准，并受益于患者和公众的大力参与。与四个参与EMS内的决策者进行早期和持续的协商，形成了一种协调一致的研究设置方法。所有接收医院均给予批准并同意收集数据。实施了一个全面的数据库以及培训和支持计划。已有超过1500名护理人员被招募到该研究中，患者入组和随访按计划进行。
EMS提供的护理需要基于证据。尽管参与者可能正经历危及生命的紧急情况，但在设计良好且管理完善的研究中，高质量的院前研究是可行的。这里描述的方法可用于支持成功的研究，从而改善类似患者群体的治疗和预后。
ISRCTN08256118。于2014年7月22日注册。
