Hospital Airway Resuscitation Trial

Respiratory Failure Clinical Trial

— HART  

Official title:

Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520762
• Other study ID #: 2021-13691
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Respiratory Failure
• Respiratory Insufficiency

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