Hospital Airway Resuscitation Trial (HART)

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Respiratory Failure; Cardiac Arrest

Treatments: Procedure: A strategy of first choice supraglottic airway; Procedure: A strategy of first choice endotracheal intubation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05520762

2021-13691

R33HL162980 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,060 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult aged >=18 years
2. Admitted to the hospital for any condition
3. Suffered in-hospital cardiac arrest (loss of pulse and ≥2 minutes of chest compressions)
4. Need for assisted ventilation (defined by initiation of bag-mask-ventilation or other supported ventilation)

Exclusion criteria

1. Cardiac arrest in the Operating Room or other area not responded to by Critical Care/Emergency Department (ED) teams.
2. Cardiac arrest in which an invasive airway (i.e. endotracheal tube, tracheostomy tube) is already in place
3. Patients with Do Not Resuscitate or Do Not Intubate orders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,060 participants in 2 patient groups

First choice supraglottic airway device, Then First choice endotracheal intubation

Experimental group

Description:

A strategy of 'first choice' supraglottic airway during cardiac arrest. Clinicians can deviate to the airway management approach of their choice if deemed to be in the best interest of the patient. As part of a cluster-randomized design, hospitals (4 in the system) will be assigned to one arm for a month and then cross-over to the other arm.

Treatment:

Procedure: A strategy of first choice endotracheal intubation

Procedure: A strategy of first choice supraglottic airway

First choice endotracheal intubation, Then First choice supraglottic airway

Active Comparator group

Description:

A strategy of 'first choice' endotracheal intubation during cardiac arrest. Clinicians can deviate to the airway management approach of their choice if deemed to be in the best interest of the patient. As part of a cluster-randomized design, hospitals (4 in the system) will be assigned to one arm for a month and then cross-over to the other arm.

Treatment:

Procedure: A strategy of first choice endotracheal intubation

Procedure: A strategy of first choice supraglottic airway