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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from initiation of chest compressions to advanced airway placement
Awards & highlights
HART Trial 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.Check my eligibility
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.See study design
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.
HART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently admitted to the hospital.
Select...
I require help with breathing through a machine.
Select...
I had a cardiac arrest in the hospital and received CPR for at least 2 minutes.
HART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alive-and-ventilator free days
Secondary outcome measures
72-hour survival
Chest compression fraction
Modified Rankin Scale
+6 moreHART 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.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
581,136 Total Patients Enrolled
1 Trials studying Cardiac Arrest
1,000 Patients Enrolled for Cardiac Arrest
Ari Moskowitz, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
95 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently admitted to the hospital.I have had a cardiac arrest and already have a breathing tube in place.I had a cardiac arrest in a place without critical care or ED response.I am 18 years old or older.I require help with breathing through a machine.You have specific medical orders saying that you should not be resuscitated or put on a ventilator.I had a cardiac arrest in the hospital and received CPR for at least 2 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: First choice supraglottic airway device, Then First choice endotracheal intubation
- Group 2: First choice endotracheal intubation, Then First choice supraglottic airway
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current opportunities to participate in this clinical trial?
"According to the information available on clinicaltrials.gov, this particular medical study has ceased its recruitment efforts for now. It was initially posted in December of 2022 and underwent its latest update in August of that same year. Nevertheless, there are 241 other trials recruiting at this current moment."
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