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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05520762
Other study ID # 2021-13691
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 6, 2023
Est. completion date February 2027

Study information

Verified date November 2023
Source Montefiore Medical Center
Contact Ari Moskowitz, MD
Phone 718-920-5440
Email amoskowitz@montefiore.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Procedure:
A strategy of first choice supraglottic airway
See description in Arms section
A strategy of first choice endotracheal intubation
See description in Arms section

Locations

Country Name City State
United States Montefiore Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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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