Hospital Airway Resuscitation Trial

摘要

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.