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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,060
See description in Arms section
See description in Arms section
Montefiore Medical Center
New York, New York, United States
RECRUITINGAlive-and-ventilator free days
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.
Time frame: From cardiac arrest until 28-days after cardiac arrest
Return of spontaneous circulation (ROSC)
ROSC will be assessed. ROSC is defined as having ≥20 minutes of continuous spontaneous circulation without chest compressions. Rates of ROSC will be summarized by study arm using basic descriptive statistics.
Time frame: Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
72 hour survival
Survival to 72 hour after in-hospital cardiac arrest (IHCA) event will be summarized by study arm using basic descriptive statistics.
Time frame: From IHCA event until 72 hours after IHCA event
28 day survival
Survival to 28 days after cardiac IHCA event will be summarized by study arm using basic descriptive statistics.
Time frame: From IHCA event until 28 days after IHCA event
Functional Outcome at Discharge
Functional Outcome at Discharge will be measured using the modified Rankin Scale (mRS). The mRS is a clinical tool that measures the patient's function disability (ability to perform daily living activities). The mRS is based on a 7-point scale ranging from 0 ("No symptoms at all") to 6 ("Death") such that higher scores are associated with increased functional disability. Scores at discharge can be used as a proxy to help identify patients who may require closer follow-up given the difficulty in obtaining long-term follow-up. mRS scores will be dichotomized to identify all patients with mRS\>3 and summarized by study arm.
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Time frame: Time of hospital discharge
Survival to hospital discharge
Survival to hospital discharge, truncated at 60 days for the purposes of this outcome, will be summarized by study arm using basic descriptive statistics.
Time frame: From IHCA event until 60 days after cardiac arrest