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.
Brief Title
Hospital Airway Resuscitation Trial
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
718-920-5440
Central Contact Email
amoskowitz@montefiore.org
Completion Date
Completion Date Type
Estimated
Conditions
Cardiac Arrest
Respiratory Failure
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
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
Inclusion 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)
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)
Gender
All
Gender Based
false
Keywords
Cardiac Arrest
Emergency Airway Management
In-hospital Cardiac Arrest
Endotracheal Intubation
Supraglottic Airway
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05520762
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-13691
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
Primary Outcomes
Outcome Description
Days alive and free of mechanical ventilation.
Outcome Measure
Alive-and-ventilator free days
Outcome Time Frame
From cardiac arrest until 28-days after cardiac arrest
Secondary Ids
Secondary Id
R33HL162980
Secondary Outcomes
Outcome Description
Rate of ROSC. ROSC defined as 20 minutes of continuous spontaneous circulation without chest compressions.
Outcome Time Frame
Onset of cardiac arrest until either ROSC or death up to 24 hours
Outcome Measure
Return of spontaneous circulation (ROSC)
Outcome Description
Survival to 72-hour after cardiac arrest
Outcome Time Frame
From cardiac arrest until 72 hours after cardiac arrest
Outcome Measure
72-hour survival
Outcome Description
Survival to hospital discharge, truncated at 60 days
Outcome Time Frame
Cardiac arrest until 60 days after cardiac arrest
Outcome Measure
Survival to hospital discharge
Outcome Description
Number of prolonged pauses (\>5 seconds) in chest compressions during active Cardiopulmonary Resuscitation (CPR)
Outcome Time Frame
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Outcome Measure
Prolonged pauses
Outcome Description
Percentage of total cardiac arrest time during which chest compressions are being performed
Outcome Time Frame
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Outcome Measure
Chest compression fraction
Outcome Description
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
Outcome Time Frame
Cardiac arrest until 7 days after cardiac arrest
Outcome Measure
Rate of ventilator-associated pneumonia (VAP)
Outcome Description
Modified Rankin Scale (mRS) at time of hospital discharge
Outcome Time Frame
Time of hospital discharge
Outcome Measure
Modified Rankin Scale
Outcome Description
Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
Outcome Time Frame
Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
Outcome Measure
Time to epinephrine
Outcome Description
Time from initiation of chest compressions to advanced airway placement
Outcome Time Frame
Time from initiation of chest compressions to advanced airway placement
Outcome Measure
Time to advanced airway
Outcome Description
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
Outcome Time Frame
At time of cardiac arrest, less than one day
Outcome Measure
Number of Overall Pauses in Chest Compression
Outcome Description
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.
Outcome Time Frame
At time of cardiac arrest, less than one day
Outcome Measure
Longest Overall Pause in Chest Compression
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ari Moskowitz
Investigator Email
amoskowitz@montefiore.org