Hospital Airway Resuscitation Trial (HART)

November 18, 2025 updated by: Montefiore Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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/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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From cardiac arrest until 28-days after cardiac arrest
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.
From cardiac arrest until 28-days after cardiac arrest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return of spontaneous circulation (ROSC)
Time Frame: Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
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.
Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
72 hour survival
Time Frame: From IHCA event until 72 hours after IHCA event
Survival to 72 hour after in-hospital cardiac arrest (IHCA) event will be summarized by study arm using basic descriptive statistics.
From IHCA event until 72 hours after IHCA event
28 day survival
Time Frame: From IHCA event until 28 days after IHCA event
Survival to 28 days after cardiac IHCA event will be summarized by study arm using basic descriptive statistics.
From IHCA event until 28 days after IHCA event
Functional Outcome at Discharge
Time Frame: Time of hospital discharge
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.
Time of hospital discharge
Survival to hospital discharge
Time Frame: From IHCA event until 60 days after cardiac arrest
Survival to hospital discharge, truncated at 60 days for the purposes of this outcome, will be summarized by study arm using basic descriptive statistics.
From IHCA event until 60 days after cardiac arrest

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to epinephrine
Time Frame: 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 from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
Time to advanced airway
Time Frame: Time from initiation of chest compressions to advanced airway placement
Time from initiation of chest compressions to advanced airway placement
Time from initiation of chest compressions to advanced airway placement
Prolonged pauses
Time Frame: From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
The number of prolonged pauses, defined as pauses lasting >5 seconds in duration, in chest compressions during active Cardiopulmonary Resuscitation (CPR) will be determined. Prolonged pauses will be summarized by study arm using basic descriptive statistics.
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Rate of ventilator-associated pneumonia (VAP)
Time Frame: Cardiac arrest until 7 days after cardiac arrest
Rate of VAP in the 7 days after cardiac arrest. VAP defined as new pneumonia while receiving mechanical ventilation after cardiac arrest. New pneumonia will be 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. Rates of VAP will be summarized by study arm using basic descriptive statistics.
Cardiac arrest until 7 days after cardiac arrest
Chest compression fraction
Time Frame: From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Percentage of total cardiac arrest time during which chest compressions are being performed will be determined. Results will be summarized by study arm using basic descriptive statistics.
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Longest Overall Pause in Chest Compression
Time Frame: At time of cardiac arrest, less than one day
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 supraglottic airway (SGA) placement will result in chest compression pauses of shorter durations.
At time of cardiac arrest, less than one day
Number of Overall Pauses in Chest Compression
Time Frame: At time of cardiac arrest, less than one day
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
At time of cardiac arrest, less than one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 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 (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-13691
  • R33HL162980 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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