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Endotracheal Intubation

Airway Management Strategies for Cardiac Arrest (HART Trial)

N/A

Recruiting

Led By Ari Moskowitz, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted to the hospital for any condition

Need for assisted ventilation (defined by initiation of bag-mask-ventilation or other supported ventilation)

Must not have

Cardiac arrest in which an invasive airway (i.e. endotracheal tube, tracheostomy tube) is already in place

Cardiac arrest in the Operating Room or other area not responded to by critical care/ED (Emergency Department) teams

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cardiac arrest until 72 hours after cardiac arrest

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether one method of airway management during CPR is better than another.

Who is the study for?

This trial is for adults aged 18 or older who are admitted to the hospital, require assisted breathing, and have suffered an in-hospital cardiac arrest. It's not for those with 'Do Not Resuscitate' or 'Do Not Intubate' orders, already intubated at the time of arrest, or if the arrest occurs outside critical care/ED team response areas.

What is being tested?

The HART study is testing two strategies during a cardiac arrest in a hospital: using a supraglottic airway device as the first choice versus endotracheal intubation. Hospitals are randomly chosen to use one method over the other.

What are the potential side effects?

Possible side effects may include sore throat, difficulty swallowing, vocal cord damage from intubation; while less invasive methods like supraglottic airway could lead to inadequate ventilation if not properly placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently admitted to the hospital.

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I require help with breathing through a machine.

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I had a cardiac arrest in the hospital and received CPR for at least 2 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a cardiac arrest and already have a breathing tube in place.

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I had a cardiac arrest in a place without critical care or ED response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from initiation of chest compressions to advanced airway placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from initiation of chest compressions to advanced airway placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from initiation of chest compressions to advanced airway placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alive-and-ventilator free days

Secondary study objectives

72-hour survival

Chest compression fraction

Modified Rankin Scale

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: First choice supraglottic airway device, Then First choice endotracheal intubationExperimental Treatment2 Interventions

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.

Group II: First choice endotracheal intubation, Then First choice supraglottic airwayActive Control2 Interventions

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.

0 / 5Eligibility criteria met