Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,060
- 试验地点
- 1
- 主要终点
- Alive-and-ventilator free days
研究概览
简要总结
The Hospital Airway Resuscitation Trial (HART) is a cluster-randomized, pragmatic trial of advanced airway management with a strategy of first choice supraglottic airway vs. first choice endotracheal intubation during in-hospital cardiac arrest.
详细描述
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. Key outcomes for the trial will include return of spontaneous circulation, alive-and-ventilator-free days, and hospital survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged >=18 years
- •Admitted to the hospital for any condition
- •Suffered in-hospital cardiac arrest (loss of pulse and ≥2 minutes of chest compressions)
- •Need for assisted ventilation (defined by initiation of bag-mask-ventilation or other supported ventilation)
排除标准
- •Cardiac arrest in the Operating Room or other area not responded to by Critical Care/Emergency Department (ED) teams.
- •Cardiac arrest in which an invasive airway (i.e. endotracheal tube, tracheostomy tube) is already in place
- •Patients with Do Not Resuscitate or Do Not Intubate orders
结局指标
主要结局
Alive-and-ventilator free days
时间窗: From cardiac arrest until 28-days after cardiac arrest
The number of days a patient is alive and breathing independently of invasive mechanical ventilation will be summarized by study arm using basic descriptive statistics. A patient who leaves the hospital alive and is not discharged to a hospice setting, will be considered to have lived to 28-days. A patient discharged to a hospice facility will be assessed as having died on the day of hospital discharge. A patient who is discharged on invasive mechanical ventilation, will be assumed to have remained on invasive mechanical ventilation through 28-days.
Alive-and-ventilator free days
时间窗: From cardiac arrest until 28-days after cardiac arrest
The number of days a patient is alive and breathing independently of invasive mechanical ventilation will be summarized by study arm using basic descriptive statistics. A patient who leaves the hospital alive and is not discharged to a hospice setting, will be considered to have lived to 28-days. A patient discharged to a hospice facility will be assessed as having died on the day of hospital discharge. A patient who is discharged on invasive mechanical ventilation, will be assumed to have remained on invasive mechanical ventilation through 28-days.
次要结局
- 72 hour survival(From IHCA event until 72 hours after IHCA event)
- Functional Outcome at Discharge(Time of hospital discharge)
- Survival to hospital discharge(From IHCA event until 60 days after cardiac arrest)
- Return of spontaneous circulation (ROSC)(Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours)
- 28 day survival(From IHCA event until 28 days after IHCA event)