Clinical trial NCT05520762: Hospital Airway Resuscitation Trial
Official title: Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Respiratory Failure
Keywords: Cardiac Arrest
Emergency Airway Management
In-hospital Cardiac Arrest
Endotracheal Intubation
Supraglottic Airway
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-08-30
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster-randomized design with crossover
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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/ED (Emergency Department) 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

Primary outcomes:
measure: Alive-and-ventilator free days
timeFrame: From cardiac arrest until 28-days after cardiac arrest
Secondary outcomes:
measure: Return of spontaneous circulation (ROSC)
timeFrame: Onset of cardiac arrest until either ROSC or death up to 24 hours
measure: 72-hour survival
timeFrame: From cardiac arrest until 72 hours after cardiac arrest
measure: Survival to hospital discharge
timeFrame: Cardiac arrest until 60 days after cardiac arrest
measure: Prolonged pauses
timeFrame: From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
measure: Chest compression fraction
timeFrame: From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
measure: Rate of ventilator-associated pneumonia (VAP)
timeFrame: Cardiac arrest until 7 days after cardiac arrest
measure: Modified Rankin Scale
timeFrame: Time of hospital discharge
measure: Time to epinephrine
timeFrame: Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
measure: Time to advanced airway
timeFrame: Time from initiation of chest compressions to advanced airway placement
measure: Number of Overall Pauses in Chest Compression
timeFrame: At time of cardiac arrest, less than one day
measure: Longest Overall Pause in Chest Compression
timeFrame: At time of cardiac arrest, less than one day
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Ari Moskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: