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

描述（由申请人提供）：本提案是根据RFA-HL-14-019“低成本、实用、以患者为中心的随机对照干预试验”提交的。心肺骤停是由于心脏功能和循环血液流动突然停止而引起的危重疾病。院外骤停（OHCA）是一个重大的公共卫生问题，每年影响美国30多万人，只有8%的人存活下来。成功的心脏骤停复苏需要向心脏和大脑输送救命的氧气。气道管理是打开口腔和喉咙，将氧气输送到肺部，使重要器官循环的过程。护理人员通常使用气管内插管（ETI）完成气道管理，将塑料呼吸管通过口插入气管。然而，护理人员的ETI是有风险和资源密集的。声门上气道（SGA -如王喉管，combittube和喉罩气道）是更简单的选择，但尚未证实的结果。OHCA气道管理的最佳策略尚不清楚。我们提出了一项多中心实用临床试验，比较1)ETI和2)SGA气道管理在成人OHCA护理复苏中的作用。我们将利用nhlbi资助的复苏结果联盟（ROC）的庞大现有基础设施进行试验，ROC是一个非常成功的10个城市合作，专门从事OHCA试验。本研究的目的是：具体目的一：为院外心肺骤停气道管理策略的实用试验的实施准备复苏结果联盟。根据RFA，我们将完成开展试验所需的准备工作。特定目的II：确定辅助气道管理策略（SGA vs. ETI）对成人OHCA后结果的影响。我们将验证SGA的72小时OHCA存活率高于基于eti的气道管理策略的假设。这项具有里程碑意义的试验将回答OHCA护理中最紧迫和最具争议的临床问题之一；“管理呼吸道的最佳方法是什么？”研究结果将对国际护理人员的临床实践产生直接和持久的影响。ROC是世界上唯一一个准备有效地进行这种设计和规模试验的网络。这项研究将由院外气道管理和心肺骤停领域的世界领先专家牵头。

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.