Hospital Airway Resuscitation Trial

医院气道复苏试验

• 批准号: 10722561
• 负责人: Ari Moskowitz
• 金额: $ 78.66万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722561
• 关键词: Hospital; Airway; Resuscitation; Trial

Abstract In-hospital cardiac arrest occurs in nearly 300,000 hospitalized patients in the United States each year and results in substantial morbidity and mortality. Nevertheless, the evidence base guiding the management of in- hospital cardiac arrest is quite limited and society guidelines generally extrapolate data from the out-of-hospital cardiac setting to inform in-hospital arrest care. As compared to out-of-hospital arrest, however, in-hospital arrest victims tend to have more medical comorbidities, have a witnessed arrest, and be attended to by professional first responders with advanced monitoring and treatment capabilities. Advanced airway management is a key element of cardiac arrest resuscitation. The American Heart Association makes broad recommendations regarding airway management during in-hospital cardiac, supporting endotracheal intubation (a complex procedure requiring placement of an endotracheal tube through the vocal cords) and supraglottic airway placement (a less complex advanced airway modality wherein the device is placed blindly in the supraglottic space). Data from the out-of-hospital cardiac arrest setting has found that a supraglottic airway strategy may be similar or superior to a more complex endotracheal intubation strategy. There is no randomized data to guide practice in the in-hospital setting. We intend to address this knowledge gap by performing the Hospital Airway Resuscitation Trial (HART)—a highly-innovative, pragmatic cluster-randomized trial leveraging the unified clinical and research infrastructure within the Montefiore HealthSystem (New York City) to conduct a first-of-its-kind in-hospital arrest trial in a highly diverse patient population. Specifically, a mixture of academic and community hospitals within the MontefioreHealth system will be randomized to either a strategy of first-choice endotracheal intubation or a strategy of first choice supraglottic airway, with crossovers occurring at regular intervals. The primary outcome for the trial will be alive-and-ventilator-free days, a common outcome in critical care trials that accounts for the impact of the intervention on both morbidity and mortality. We hypothesize that in-hospital arrest patients managed with a strategy of first-choice supraglottic airway will have more alive-and-ventilator-free days than those managed with a strategy of endotracheal intubation. Secondary outcomes will include rates of return of spontaneous circulation, survival to 72-hours and 28-days, and functional status at discharge. In addition, we aim to understand mechanistic explanations for the efficacy of airway management strategies by comparing accepted metrics of cardiopulmonary resuscitation quality between groups. This will be done using data captured by state-of-the-art bedside advanced cardiac monitors/defibrillators in use throughout the Montefiore system. We will enroll 1060 patients in this trial. The results of this trial promise to impact airway management strategies during in-hospital cardiac arrest worldwide and, if our hypothesis is true, result in a substantial number of lives saved.

摘要 在美国，每年有近30万住院患者发生院内心脏骤停， 导致相当高的发病率和死亡率。然而，指导管理的证据基础- 医院心脏骤停是非常有限的，社会指南通常从医院外的数据推断 心脏设置，以告知住院心脏骤停护理。然而，与院外逮捕相比， 逮捕受害者往往有更多的医疗合并症，有目击者逮捕，并由 专业的第一反应者，具有先进的监测和治疗能力。高级气道 处理是心脏骤停复苏的关键要素。美国心脏协会广泛 关于院内心脏辅助气管插管期间气道管理的建议 （需要通过声带放置气管内导管的复杂手术）和声门上 气道放置（一种不太复杂的高级气道模式，其中该装置被盲置于 声门上间隙）。来自院外心脏骤停设置的数据发现， 该策略可以类似于或上级于更复杂气管内插管策略。没有 随机数据，以指导实践在医院的设置。我们打算通过以下方式弥补这一知识差距： 进行医院气道复苏试验（哈特）-一项高度创新、务实的随机分组试验， 利用Montefiore HealthSystem（纽约）内统一的临床和研究基础设施的试验 市）进行首次在医院逮捕试验在一个高度多样化的患者群体。特别是 MontefioreHealth系统内的学术和社区医院将被随机分配到 首选气管插管策略或首选声门上气道策略， 有规律的交叉试验的主要结局是存活和无呼吸机 天，这是重症监护试验中的一个常见结果，该试验解释了干预对发病率和死亡率的影响。 and mortality.我们假设，在医院的逮捕病人管理的战略，第一选择 声门上气道将有更多的生存和无呼吸机的日子比那些管理的策略， 气管插管次要结局将包括自主循环的恢复率， 72-小时和28天，以及出院时的功能状态。此外，我们的目标是了解机械 通过比较气道管理策略的公认指标， 组间心肺复苏质量比较。这将通过使用最先进的 在整个Montefiore系统中使用的床旁高级心脏监护仪/除颤器。我们将招收1060名 患者在此次试验中这项试验的结果有望影响住院期间的气道管理策略， 如果我们的假设是正确的，这将挽救大量的生命。