Airway Management Strategies for Cardiac Arrest

(HART Trial)

Overseen By Ari L. Moskowitz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Operating room, Invasive airway, DNR/DNI

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month per strategy with crossovers

1060 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage airways during cardiac arrest in a hospital setting. It compares two strategies: first using a supraglottic airway (a device placed above the vocal cords) versus first using endotracheal intubation (a tube inserted into the windpipe). Hospitals will alternate between these methods to determine which is more effective. This trial targets adults in the hospital who have experienced cardiac arrest and require breathing assistance. As an unphased trial, it seeks to improve emergency care practices, potentially benefiting future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these airway management strategies are safe for cardiac arrest patients?

Research shows that both supraglottic airway devices and endotracheal intubation are often used in emergencies like cardiac arrest. Studies have found that patients generally handle the supraglottic airway device with ease. For instance, one study found no major difference in patient outcomes when using this device compared to endotracheal intubation during out-of-hospital cardiac arrests.

However, endotracheal intubation can pose some risks. A study found that 45.2% of patients experienced at least one major issue after intubation, with heart-related problems in 42.6% and very low oxygen levels in 9.3% of patients. Despite these risks, skilled professionals often perform the procedure successfully.

In summary, both methods are widely used and considered relatively safe in controlled settings. However, endotracheal intubation may carry more risks compared to supraglottic airway devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different airway management strategies for cardiac arrest, which could lead to better patient outcomes. The study compares the use of a supraglottic airway device as the first choice, followed by endotracheal intubation, against the reverse order. Unlike the traditional approach where endotracheal intubation is commonly prioritized, this trial investigates the potential benefits of starting with a supraglottic airway device, which may be quicker and easier to administer in emergency situations. By testing these strategies in a real-world, hospital setting, researchers hope to gain insights into which method provides the best outcomes, potentially reshaping standard practices for managing cardiac arrest.

What evidence suggests that these airway management strategies are effective for cardiac arrest?

This trial will compare two airway management strategies during cardiac arrest: using a supraglottic airway device, such as the i-gel, as the first choice, and using endotracheal intubation as the first choice. Research has shown that devices like the i-gel, which keep the airway open, are more successful in emergencies than traditional methods. These devices are easier to use and can quickly assist breathing during a heart attack. Studies have found that survival rates for heart attacks in hospitals are usually low, but these devices might improve outcomes due to their simplicity.

For endotracheal intubation, evidence indicates it has been a common airway management method for a long time. However, it requires more skill and time to perform correctly. Both methods have advantages, and the choice often depends on the situation and the healthcare provider's experience. Overall, both aim to ensure the patient receives enough oxygen during a heart attack. ^{6 7 8 9 10}

Who Is on the Research Team?

Ari L. Moskowitz, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently admitted to the hospital.

I require help with breathing through a machine.

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

Exclusion Criteria

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.

You have specific medical orders saying that you should not be resuscitated or put on a ventilator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo advanced airway management during in-hospital cardiac arrest with either supraglottic airway or endotracheal intubation strategies

1 month per strategy with crossovers

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for outcomes such as return of spontaneous circulation, ventilator-free days, and survival to hospital discharge

Up to 60 days

What Are the Treatments Tested in This Trial?

Interventions

• A strategy of first choice endotracheal intubation
• A strategy of first choice supraglottic airway

Trial Overview

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.

How Is the Trial Designed?

Group I: First choice supraglottic airway device, Then First choice endotracheal intubation Experimental Treatment 2 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 airway Active Control 2 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.

A strategy of first choice endotracheal intubation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Endotracheal Intubation for:

• Airway management during in-hospital cardiac arrest

Approved in European Union as Tracheal Intubation for:

• Airway management during cardiac arrest
• Respiratory failure

Approved in Canada as Endotracheal Intubation for:

• Airway management during cardiac arrest
• Anesthesia

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 481 asthmatic patients starting ICS/LABA treatment, older age and higher doses of inhaled corticosteroids were identified as significant risk factors for developing local oropharyngeal and laryngeal adverse effects (LOLAE).

Patients experiencing LOLAE were generally younger smokers with fewer pack-years of smoking, suggesting that the type of inhaled corticosteroid used also plays a role in the likelihood of these adverse effects, highlighting the need for careful selection and dosage in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors of local oropharyngeal and laryngeal adverse effects from use of single inhaled corticosteroids and long-acting beta-agonists. Horita, N., To, M., Araki, K., et al.[2012]

The laryngeal mask airway (LMA) significantly improves ventilation in patients who are difficult to intubate, especially in those with facial tumors, compared to traditional face masks.

Fibreoptic intubation through the LMA was successful in all cases, making it easier than other methods, while blind intubation was successful in about 22% of difficult cases, indicating that the LMA is a valuable tool in managing challenging intubations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The laryngeal mask airway in the difficult intubation. The results of a prospective study]. Langenstein, H.[2019]

Most pulmonologists agree that using short-acting beta-2 agonists (SABA) alone for asthma treatment is no longer safe or recommended, aligning with the latest GINA guidelines.

Despite this understanding, some pulmonologists still prescribe SABA alone, indicating a need for better implementation of the recommended combination therapy of inhaled corticosteroids and formoterol, especially in early treatment steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICS/formoterol in the management of asthma in the clinical practice of pulmonologists: an international survey on GINA strategy. Cruz, ÁA., Barile, S., Nudo, E., et al.[2021]

A large observational study involving 649,359 out-of-hospital cardiac arrests found that bag-mask ventilation was associated with a higher chance of neurologically favorable survival compared to supraglottic airway (SGA) insertion or tracheal intubation.

Recent studies suggest that tracheal intubation may be more effective than SGA during cardiac arrest, but these findings are limited by potential confounding factors, highlighting the need for well-designed randomized trials to determine the best airway management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in cardiopulmonary resuscitation. Soar, J., Nolan, JP.[2013]

In a study involving 46 novice doctors, the i-gel intubating laryngeal mask airway (LMA) was found to allow for significantly faster successful ventilation compared to the Aura-i, both during initial evaluation and after a 90-day retention period.

Participants preferred the i-gel for its ease of use, although both LMAs showed acceptable skill retention over three months, with a notable increase in time to successful ventilation during the re-evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of learning performance of 2 intubating laryngeal mask airways in novice: A randomized crossover manikin study. Liu, ZJ., Yi, J., Chen, WY., et al.[2021]

In the AIRWAYS-2 trial involving 9296 patients with out-of-hospital cardiac arrest, the use of the i-gel supraglottic airway device showed no significant difference in recovery outcomes compared to tracheal intubation at both 30 days and 6 months post-treatment.

The study found that 8.3% of patients survived to 30 days, and follow-up at 6 months revealed similar quality of life scores between the two airway management strategies, indicating that both methods are equally effective for advanced airway management in this emergency setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months. Benger, JR., Lazaroo, MJ., Clout, M., et al.[2021]

Recent evidence suggests that advanced airway management techniques, like tracheal intubation, may be associated with worse neurological outcomes during the first 15 minutes of cardiac arrest, compared to not intubating during that critical period.

A large randomized clinical trial involving 2043 patients found no significant difference in favorable neurological outcomes between tracheal intubation and bag-mask ventilation when intubation was delayed until after return of spontaneous circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To intubate or not to intubate? Gough, CJR., Nolan, JP.[2019]

In a study involving 26,442 patients aged 55 and older, initiating treatment with tiotropium for COPD did not increase the risk of cardiovascular events compared to long-acting beta2-agonists (LABA) within the first year of treatment.

Tiotropium was associated with a significantly lower incidence of pneumonia compared to LABA, suggesting that LABA, often combined with inhaled corticosteroids, may increase pneumonia risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Acting Bronchodilator Initiation in COPD and the Risk of Adverse Cardiopulmonary Events: A Population-Based Comparative Safety Study. Suissa, S., Dell'Aniello, S., Ernst, P.[2018]

In a study of 155,252 patients across 656 hospitals, 69.7% received endotracheal intubation during CPR for in-hospital cardiac arrest, but overall survival to hospital discharge was only 24.8%.

There was a strong inverse relationship between the rate of endotracheal intubation and survival to discharge, particularly in patients without respiratory failure prior to arrest, suggesting that high intubation rates may negatively impact survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective cohort study of hospital variation in airway management during in-hospital cardiac arrest and the association with patient survival: insights from Get With The Guidelines-Resuscitation. Bradley, SM., Zhou, Y., Ramachandran, SK., et al.[2020]

In a study involving 9296 patients treated by 1382 paramedics, the use of the i-gel supraglottic airway device and tracheal intubation showed no significant difference in quality-adjusted life years (QALYs) after six months, indicating similar effectiveness in managing out-of-hospital cardiac arrest.

While tracheal intubation was slightly less costly than the i-gel device (£3570 vs. £3413), the differences in both costs and health outcomes were minimal, suggesting that both airway management strategies are comparably cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial. Stokes, EA., Lazaroo, MJ., Clout, M., et al.[2021]

A cluster-randomized trial involving 184 paramedics assessed the feasibility of comparing the i-gel and laryngeal mask airway supreme (LMAS) against usual practice for advanced airway management during out-of-hospital cardiac arrest (OHCA).

The study successfully recruited 615 patients and demonstrated that conducting a trial on airway management strategies in OHCA is feasible, although the LMAS arm was suspended due to adverse incidents, and no significant differences in patient outcomes were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised comparison of the effectiveness of the laryngeal mask airway supreme, i-gel and current practice in the initial airway management of out of hospital cardiac arrest: a feasibility study. Benger, J., Coates, D., Davies, S., et al.[2022]

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