Hospital Airway Resuscitation Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial

Conditions
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Cardiac Arrest, Respiratory Failure

Intervention / Treatment
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* Procedure: A strategy of first choice supraglottic airway
* Procedure: A strategy of first choice endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Cardiac arrest in the Operating Room or other area not responded to by critical care/ED (Emergency Department) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster-randomized design with crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First choice supraglottic airway device, Then First choice endotracheal intubation<br>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. | Procedure: A strategy of first choice supraglottic airway<br>* See description in Arms section<br>Procedure: A strategy of first choice endotracheal intubation<br>* See description in Arms section<br>|
| Active Comparator: First choice endotracheal intubation, Then First choice supraglottic airway<br>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. | Procedure: A strategy of first choice supraglottic airway<br>* See description in Arms section<br>Procedure: A strategy of first choice endotracheal intubation<br>* See description in Arms section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive-and-ventilator free days | Days alive and free of mechanical ventilation. | From cardiac arrest until 28-days after cardiac arrest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of spontaneous circulation (ROSC) | Rate of ROSC. ROSC defined as 20 minutes of continuous spontaneous circulation without chest compressions. | Onset of cardiac arrest until either ROSC or death up to 24 hours | 
| 72-hour survival | Survival to 72-hour after cardiac arrest | From cardiac arrest until 72 hours after cardiac arrest | 
| Survival to hospital discharge | Survival to hospital discharge, truncated at 60 days | Cardiac arrest until 60 days after cardiac arrest | 
| Prolonged pauses | Number of prolonged pauses (>5 seconds) in chest compressions during active Cardiopulmonary Resuscitation (CPR) | From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours | 
| Chest compression fraction | Percentage of total cardiac arrest time during which chest compressions are being performed | From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours | 
| Rate of ventilator-associated pneumonia (VAP) | Rate of VAP in the 7 days after cardiac arrest. VAP defined as new pneumonia while receiving mechanical ventilation after cardiac arrest. New pneumonia defined by 1) new pulmonary infiltrate on chest imaging 2) either new/worsening fever or leukocytosis 3) either change in sputum composition/frequency or worsening gas exchange or new/worsening cough or dyspnea | Cardiac arrest until 7 days after cardiac arrest | 
| Modified Rankin Scale | Modified Rankin Scale (mRS) at time of hospital discharge | Time of hospital discharge | 
| Time to epinephrine | Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm | Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm | 
| Time to advanced airway | Time from initiation of chest compressions to advanced airway placement | Time from initiation of chest compressions to advanced airway placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway