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Hospital Airway Resuscitation Trial (HART)

Primary Purpose

Cardiac Arrest, Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A strategy of first choice supraglottic airway
A strategy of first choice endotracheal intubation
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult aged >17 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 clear asphyxia arrest due to upper airway obstruction (e.g. foreign body, angioedema, malignancy) as determined the clinical team
  4. Patients with Do Not Resuscitate or Do Not Intubate orders

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

First choice supraglottic airway device, Then First choice endotracheal intubation

First choice endotracheal intubation, Then First choice supraglottic airway

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Alive-and-ventilator free days
Days alive and free of mechanical ventilation.

Secondary Outcome Measures

Return of spontaneous circulation (ROSC)
Rate of ROSC. ROSC defined as 20 minutes of continuous spontaneous circulation without chest compressions.
72-hour survival
Survival to 72-hour after cardiac arrest
Survival to hospital discharge
Survival to hospital discharge, truncated at 60 days
Prolonged pauses
Number of prolonged pauses (>5 seconds) in chest compressions during active Cardiopulmonary Resuscitation (CPR)
Chest compression fraction
Percentage of total cardiac arrest time during which chest compressions are being performed
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
Modified Rankin Scale
Modified Rankin Scale (mRS) at 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 to advanced airway
Time from initiation of chest compressions to advanced airway placement

Full Information

First Posted
August 22, 2022
Last Updated
February 9, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05520762
Brief Title
Hospital Airway Resuscitation Trial
Acronym
HART
Official Title
Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Respiratory Failure
Keywords
Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cluster-randomized design with crossover
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1060 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
First choice supraglottic airway device, Then First choice endotracheal intubation
Arm Type
Experimental
Arm Description
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.
Arm Title
First choice endotracheal intubation, Then First choice supraglottic airway
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
A strategy of first choice supraglottic airway
Intervention Description
See description in Arms section
Intervention Type
Procedure
Intervention Name(s)
A strategy of first choice endotracheal intubation
Intervention Description
See description in Arms section
Primary Outcome Measure Information:
Title
Alive-and-ventilator free days
Description
Days alive and free of mechanical ventilation.
Time Frame
From cardiac arrest until 28-days after cardiac arrest
Secondary Outcome Measure Information:
Title
Return of spontaneous circulation (ROSC)
Description
Rate of ROSC. ROSC defined as 20 minutes of continuous spontaneous circulation without chest compressions.
Time Frame
Onset of cardiac arrest until either ROSC or death up to 24 hours
Title
72-hour survival
Description
Survival to 72-hour after cardiac arrest
Time Frame
From cardiac arrest until 72 hours after cardiac arrest
Title
Survival to hospital discharge
Description
Survival to hospital discharge, truncated at 60 days
Time Frame
Cardiac arrest until 60 days after cardiac arrest
Title
Prolonged pauses
Description
Number of prolonged pauses (>5 seconds) in chest compressions during active Cardiopulmonary Resuscitation (CPR)
Time Frame
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Title
Chest compression fraction
Description
Percentage of total cardiac arrest time during which chest compressions are being performed
Time Frame
From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours
Title
Rate of ventilator-associated pneumonia (VAP)
Description
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
Time Frame
Cardiac arrest until 7 days after cardiac arrest
Title
Modified Rankin Scale
Description
Modified Rankin Scale (mRS) at time of hospital discharge
Time Frame
Time of hospital discharge
Title
Time to epinephrine
Description
Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
Time Frame
Time from initiation of chest compressions to first epinephrine for cardiac arrest with initial non-shockable rhythm
Title
Time to advanced airway
Description
Time from initiation of chest compressions to advanced airway placement
Time Frame
Time from initiation of chest compressions to advanced airway placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult aged >=18 years Admitted to the hospital for any condition Suffered in-hospital cardiac arrest (loss of pulse and ≥2 minutes of chest compressions) Need for assisted ventilation (defined by initiation of bag-mask-ventilation or other supported ventilation) Exclusion Criteria: Cardiac arrest in the Operating Room or other area not responded to by critical care/ED (Emergency Department) teams. Cardiac arrest in which an invasive airway (i.e. endotracheal tube, tracheostomy tube) is already in place Patients with Do Not Resuscitate or Do Not Intubate orders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ari Moskowitz, MD
Phone
718-920-5440
Email
amoskowitz@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Moskowitz, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari Moskowitz, MD
Phone
718-920-5440
Email
amoskowitz@montefiore.org
First Name & Middle Initial & Last Name & Degree
Daniel Ceusters
Phone
718-920-5440
Email
dceuster@montefiore.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be shared in de-identified fashion

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Hospital Airway Resuscitation Trial

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