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/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
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
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
Estimated
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
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.
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
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.
Outcome Time Frame
Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
Outcome Measure
Return of spontaneous circulation (ROSC)
Outcome Description
Survival to 72 hour after in-hospital cardiac arrest (IHCA) event will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
From IHCA event until 72 hours after IHCA event
Outcome Measure
72 hour survival
Outcome Description
Survival to 28 days after cardiac IHCA event will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
From IHCA event until 28 days after IHCA event
Outcome Measure
28 day survival
Outcome Description
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.
Outcome Time Frame
Time of hospital discharge
Outcome Measure
Functional Outcome at Discharge
Outcome Description
Survival to hospital discharge, truncated at 60 days for the purposes of this outcome, will be summarized by study arm using basic descriptive statistics.
Outcome Time Frame
From IHCA event until 60 days after cardiac arrest
Outcome Measure
Survival to hospital discharge
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
Locked Fields
Render the field
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
Investigator Department
Medicine
Investigator Division
Critical Care
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
Critical Care Medicine
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
HEART ARREST
RESPIRATORY INSUFFICIENCY
HEART DISEASES
CARDIOVASCULAR DISEASES
RESPIRATION DISORDERS
RESPIRATORY TRACT DISEASES