Respiratory Failure Clinical Trial
— HARTOfficial title:
Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
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.
Status | Recruiting |
Enrollment | 1060 |
Est. completion date | February 2027 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alive-and-ventilator free days | Days alive and free of mechanical ventilation. | From cardiac arrest until 28-days after cardiac arrest | |
Secondary | 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 | |
Secondary | 72-hour survival | Survival to 72-hour after cardiac arrest | From cardiac arrest until 72 hours after cardiac arrest | |
Secondary | Survival to hospital discharge | Survival to hospital discharge, truncated at 60 days | Cardiac arrest until 60 days after cardiac arrest | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Modified Rankin Scale | Modified Rankin Scale (mRS) at time of hospital discharge | Time of hospital discharge | |
Secondary | 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 | |
Secondary | Time to advanced airway | Time from initiation of chest compressions to advanced airway placement | Time from initiation of chest compressions to advanced airway placement |
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