Hospital Airway Resuscitation Trial
- Conditions
- Cardiac ArrestRespiratory Failure
- Interventions
- Procedure: A strategy of first choice supraglottic airwayProcedure: A strategy of first choice endotracheal intubation
- Registration Number
- NCT05520762
- Lead Sponsor
- Montefiore Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1060
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First choice endotracheal intubation, Then First choice supraglottic airway A strategy of first choice supraglottic airway 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. First choice endotracheal intubation, Then First choice supraglottic airway A strategy of first choice endotracheal intubation 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. First choice supraglottic airway device, Then First choice endotracheal intubation A strategy of first choice endotracheal intubation 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. First choice supraglottic airway device, Then First choice endotracheal intubation A strategy of first choice supraglottic airway 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.
- Primary Outcome Measures
Name Time Method Alive-and-ventilator free days From cardiac arrest until 28-days after cardiac arrest Days alive and free of mechanical ventilation.
- Secondary Outcome Measures
Name Time Method Return of spontaneous circulation (ROSC) Onset of cardiac arrest until either ROSC or death up to 24 hours Rate of ROSC. ROSC defined as 20 minutes of continuous spontaneous circulation without chest compressions.
72-hour survival From cardiac arrest until 72 hours after cardiac arrest Survival to 72-hour after cardiac arrest
Survival to hospital discharge Cardiac arrest until 60 days after cardiac arrest Survival to hospital discharge, truncated at 60 days
Prolonged pauses From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours Number of prolonged pauses (\>5 seconds) in chest compressions during active Cardiopulmonary Resuscitation (CPR)
Chest compression fraction From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours Percentage of total cardiac arrest time during which chest compressions are being performed
Rate of ventilator-associated pneumonia (VAP) Cardiac arrest until 7 days after cardiac arrest 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
Modified Rankin Scale Time of hospital discharge Modified Rankin Scale (mRS) at 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
Number of Overall Pauses in Chest Compression At time of cardiac arrest, less than one day The number of overall pauses in chest compression, greater than 5 seconds in duration, will be summarized by arm using basic descriptive statistics. It is hypothesized that SGA placement will result in fewer chest compression pauses
Longest Overall Pause in Chest Compression At time of cardiac arrest, less than one day The duration of the longest overall pause in chest compression will be determined. This interval will be summarized by arm using basic descriptive statistics. It is hypothesized that SGA placement will result in chest compression pauses of shorter durations.
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸New York, New York, United States