Cardiac Arrest, Respiratory Failure
Conditions
Keywords
Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway
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.
Interventions
PROCEDUREA strategy of first choice supraglottic airway
See description in Arms section
PROCEDUREA strategy of first choice endotracheal intubation
See description in Arms section
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster-randomized design with crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alive-and-ventilator free days | From cardiac arrest until 28-days after cardiac arrest | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return of spontaneous circulation (ROSC) | Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours | 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. |
| 72 hour survival | From IHCA event until 72 hours after IHCA event | Survival to 72 hour after in-hospital cardiac arrest (IHCA) event will be summarized by study arm using basic descriptive statistics. |
| 28 day survival | From IHCA event until 28 days after IHCA event | Survival to 28 days after cardiac IHCA event will be summarized by study arm using basic descriptive statistics. |
| Functional Outcome at Discharge | Time of hospital 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. |
| Survival to hospital discharge | From IHCA event until 60 days after cardiac arrest | Survival to hospital discharge, truncated at 60 days for the purposes of this outcome, will be summarized by study arm using basic descriptive statistics. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 will be determined. Results will be summarized by study arm using basic descriptive statistics. |
| 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 |
| Prolonged pauses | From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours | The number of prolonged pauses, defined as pauses lasting \>5 seconds in duration, in chest compressions during active Cardiopulmonary Resuscitation (CPR) will be determined. Prolonged pauses will be summarized by study arm using basic descriptive statistics. |
| 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 will be 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. Rates of VAP will be summarized by study arm using basic descriptive statistics. |
| Time to advanced airway | Time from initiation of chest compressions to advanced airway placement | Time from initiation of chest compressions to advanced airway placement |
| 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 supraglottic airway (SGA) placement will result in chest compression pauses of shorter durations. |
| 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 |
Countries
United States
Contacts
Primary ContactAri Moskowitz, MD
Outcome results
None listed