Hospital Airway Resuscitation Trial (HART)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Cardiac Arrest
• Intervention / Treatment: Procedure: A strategy of first choice supraglottic airway; Procedure: A strategy of first choice endotracheal intubation

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.

• Study Type: Interventional
• Enrollment (Estimated): 1060
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ari Moskowitz, MD; Phone Number: 718-920-5440; Email: amoskowitz@montefiore.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Ari Moskowitz, MD; Phone Number: 718-920-5440; Email: amoskowitz@montefiore.org
      • Contact: Daniel Ceusters; Phone Number: 718-920-5440; Email: dceuster@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First choice supraglottic airway device, Then First choice endotracheal intubation; A strategy of 'first choice' supraglottic airway during cardiac arrest. Clinicians can deviate to the airway management approach of their choice if deemed to be in the best interest of the patient. As part of a cluster-randomized design, hospitals (4 in the system) will be assigned to one arm for a month and then cross-over to the other arm.	Procedure: A strategy of first choice supraglottic airway; See description in Arms section; Procedure: A strategy of first choice endotracheal intubation; See description in Arms section
Active Comparator: First choice endotracheal intubation, Then First choice supraglottic airway; A strategy of 'first choice' endotracheal intubation during cardiac arrest. Clinicians can deviate to the airway management approach of their choice if deemed to be in the best interest of the patient. As part of a cluster-randomized design, hospitals (4 in the system) will be assigned to one arm for a month and then cross-over to the other arm.	Procedure: A strategy of first choice supraglottic airway; See description in Arms section; Procedure: A strategy of first choice endotracheal intubation; See description in Arms section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alive-and-ventilator free days	Days alive and free of mechanical ventilation.	From cardiac arrest until 28-days after cardiac arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
72-hour survival	Survival to 72-hour after cardiac arrest	From cardiac arrest until 72 hours after cardiac arrest
Survival to hospital discharge	Survival to hospital discharge, truncated at 60 days	Cardiac arrest until 60 days after cardiac arrest
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
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
Modified Rankin Scale	Modified Rankin Scale (mRS) at time of hospital discharge	Time of hospital discharge
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
Time to advanced airway	Time from initiation of chest compressions to advanced airway placement	Time from initiation of chest compressions to advanced airway placement
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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Ari Moskowitz, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Arrest; Endotracheal Intubation; Emergency Airway Management; In-hospital Cardiac Arrest; Supraglottic Airway
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Heart Arrest
• Other Study ID Numbers: 2021-13691

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared in de-identified fashion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No