Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest

描述(由申请人提供)：本提案是针对RFA-HL-14-019“低成本、务实、以患者为中心的随机对照干预试验”而提交的。心肺骤停是由于心脏功能和循环血流量突然停止而导致的危重疾病。院外心肺骤停是一个主要的公共卫生问题，在美国每年影响30多万人，只有8%的人存活。成功的心脏骤停复苏需要向心脏和大脑输送挽救生命的氧气。呼吸道管理是张开嘴巴和喉咙，将氧气输送到肺部，再循环到重要器官的过程。护理人员通常使用气管内插管(ETI)来完成呼吸道管理，即通过口腔插入塑料呼吸管并将其插入气管。然而，辅助医疗ETI是有风险和资源密集型的。声门上呼吸道(SGA--如喉王管、Combitube和喉罩呼吸道)是更简单的选择，但有未经证实的结果。目前尚不清楚适用于uchA呼吸道管理的最佳策略。我们提出了一项多中心的实用临床试验，比较1)ETI和2)SGA气道管理在辅助医疗复苏成人uchA中的作用。我们将利用NHLBI资助的复苏结果联盟(ROC)现有的大规模基础设施进行试验，ROC是一个非常成功的10个城市合作专门从事uchA试验的组织。这项研究的目的是：具体目标一：为院外心肺骤停的呼吸道管理策略的实际试验准备复苏结果联合体。根据RFA，我们将完成进行试验所需的准备任务。具体目标II：确定辅助医疗呼吸道管理策略(SGA与ETI)对成人uchA术后预后的影响。我们将检验这一假设，即使用基于SGA的气道管理策略比基于ETI的气道管理策略的uchA 72小时存活率更高。这项具有里程碑意义的试验将回答uchA护理中最紧迫和最有争议的临床问题之一：“管理呼吸道的最佳方法是什么？”这项研究结果将对国际上的辅助医疗临床实践产生直接和持久的影响。ROC是世界上唯一准备有效地进行这种设计和规模的试验的网络。这项研究将由世界领先的院外呼吸道管理和心肺骤停专家带头进行。

DESCRIPTION (provided by applicant): This proposal is submitted in response to RFA-HL-14-019 "Low-Cost, Pragmatic, Patient-Centered Randomized Controlled Intervention Trials." Cardiopulmonary arrest is the critical illness resulting from sudden cessation of heart function and circulatory blood flow. Sudden out-of-hospital cardiopulmonary arrest (OHCA) is a major public health problem, affecting over 300,000 persons in the United States each year, with only 8% surviving. Successful cardiac arrest resuscitation requires delivery of life-saving oxygen to the heart and brain. Airway management is the process of opening the mouth and throat to deliver oxygen to the lungs for circulation to the vital organs. Paramedics commonly accomplish airway management using endotracheal intubation (ETI), the insertion of a plastic breathing tube through the mouth and into the trachea. However, paramedic ETI is risky and resource intensive. Supraglottic airways (SGA - such as the King Laryngeal Tube, Combitube, and Laryngeal Mask Airway) are simpler alternatives but have unproven outcomes. The best strategy for OHCA airway management remains unknown. We propose a multicenter pragmatic clinical trial comparing 1) ETI with 2) SGA airway management in paramedic resuscitation of adult OHCA. We will carry out the trial using the massive existing infrastructure of the NHLBI-funded Resuscitation Outcomes Consortium (ROC), a highly successful 10-city collaborative specializing in OHCA trials. The aims of the study are: Specific Aim I: Prepare the Resuscitation Outcomes Consortium for execution of a pragmatic trial of airway management strategies in out-of-hospital cardiopulmonary arrest. Per the RFA, we will complete preparatory tasks necessary to carry out the trial. Specific Aim II: Determine the effect of paramedic airway management strategy (SGA vs. ETI) upon outcomes after adult OHCA. We will test the hypothesis that rates of OHCA 72-hour survival are higher with SGA- than ETI-based airway management strategies. This landmark trial will answer one of the most urgent and controversial clinical questions in OHCA care; "What is the best way to manage the airway?" The study findings will have immediate and lasting impact upon paramedic clinical practices internationally. ROC is the only network in the world poised to efficiently carry out a trial of this design and magnitude. The study will be spearheaded by the world's leading experts in out-of- hospital airway management and cardiopulmonary arrest.