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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of this treatment for cardiac arrest?

The AIRWAYS-2 trial found no significant difference in patient outcomes between using the i-gel supraglottic airway device and tracheal intubation for out-of-hospital cardiac arrest, suggesting both methods are similarly effective. ^{1 2 3 4 5}

Is airway management with devices like endotracheal intubation and supraglottic airway devices generally safe for humans?

The studies reviewed do not provide specific safety data for airway management devices like endotracheal intubation or supraglottic airway devices in humans, but they are commonly used in medical practice, suggesting a general acceptance of their safety when used by trained professionals. ^{6 7 8 9 10}

How does the treatment of using endotracheal intubation or supraglottic airway devices for cardiac arrest differ from other treatments?

This treatment is unique because it focuses on advanced airway management techniques, like endotracheal intubation (inserting a tube into the windpipe) and supraglottic airway devices (like the i-gel, which sits above the vocal cords), to help patients breathe during cardiac arrest. These methods are compared to basic airway management and are being studied for their effectiveness and cost-efficiency in emergency situations. ^{1 2 3 4 11}

Research Team

Ari L. Moskowitz, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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 am 18 years old or older.

I require help with breathing through a machine.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

To intubate or not to intubate? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Airway management in cardiopulmonary resuscitation. [2013]

3. Ireland 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. [2021]

4. England 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. [2022]

5. Ireland 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of learning performance of 2 intubating laryngeal mask airways in novice: A randomized crossover manikin study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Long-Acting Bronchodilator Initiation in COPD and the Risk of Adverse Cardiopulmonary Events: A Population-Based Comparative Safety Study. [2018]

9. England 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. [2012]

10. England pubmed.ncbi.nlm.nih.gov

ICS/formoterol in the management of asthma in the clinical practice of pulmonologists: an international survey on GINA strategy. [2021]

11. England 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. [2020]