Cardiac ArrestHARTNCT05520762
Hospital Airway Resuscitation Trial
A study testing A strategy of first choice supraglottic airway and A strategy of first choice endotracheal intubation in people with Cardiac Arrest and Respiratory Failure, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Respiratory Failure
- What is being tested?
- A strategy of first choice supraglottic airway and A strategy of first choice endotracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,083 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 3 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cardiac arrest in the Operating Room or other area not responded to by Critical Care/Emergency Department (ED) 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic 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.
Read the 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.
- Conditions
- Cardiac Arrest, Respiratory Failure
- Being tested
- A strategy of first choice supraglottic airway, A strategy of first choice endotracheal intubation
- Keywords
- Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway
- Medical subject headings
- Heart Arrest, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A strategy of first choice supraglottic airwayProcedure or surgery
See description in Arms section
A strategy of first choice endotracheal intubationProcedure or surgery
See description in Arms section
| Study group | Role | What they receive |
|---|---|---|
| First choice supraglottic airway device, Then First choice endotracheal intubation | Experimental | 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. Receives: Procedure: A strategy of first choice supraglottic airway; Procedure: A strategy of first choice endotracheal intubation |
| First choice endotracheal intubation, Then First choice supraglottic airway | Active comparator | 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. Receives: Procedure: A strategy of first choice supraglottic airway; Procedure: A strategy of first choice endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive-and-ventilator free days
The number of days a patient is alive and breathing independently of invasive mechanical ventilation will be summarized by study arm using basic descriptive statistics. A patient who leaves the hospital alive and is not discharged to a hospice setting, will be considered to have lived to 28-days. A patient discharged to a hospice facility will be assessed as having died on the day of hospital discharge. A patient who is discharged on invasive mechanical ventilation, will be assumed to have remained on invasive mechanical ventilation through 28-days.
Measured: From cardiac arrest until 28-days after cardiac arrest
Secondary outcomes (5)
Return of spontaneous circulation (ROSC)
ROSC will be assessed. ROSC is defined as having ≥20 minutes of continuous spontaneous circulation without chest compressions. Rates of ROSC will be summarized by study arm using basic descriptive statistics.
Measured: Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
72 hour survival
Survival to 72 hour after in-hospital cardiac arrest (IHCA) event will be summarized by study arm using basic descriptive statistics.
Measured: From IHCA event until 72 hours after IHCA event
28 day survival
Survival to 28 days after cardiac IHCA event will be summarized by study arm using basic descriptive statistics.
Measured: From IHCA event until 28 days after IHCA event
Functional Outcome at Discharge
Functional Outcome at Discharge will be measured using the modified Rankin Scale (mRS). The mRS is a clinical tool that measures the patient's function disability (ability to perform daily living activities). The mRS is based on a 7-point scale ranging from 0 ("No symptoms at all") to 6 ("Death") such that higher scores are associated with increased functional disability. Scores at discharge can be used as a proxy to help identify patients who may require closer follow-up given the difficulty in obtaining long-term follow-up. mRS scores will be dichotomized to identify all patients with mRS>3 and summarized by study arm.
Measured: Time of hospital discharge
Survival to hospital discharge
Survival to hospital discharge, truncated at 60 days for the purposes of this outcome, will be summarized by study arm using basic descriptive statistics.
Measured: From IHCA event until 60 days after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start10 Feb 2023
- Primary completion3 Aug 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster-randomized design with crossover
- Masking
- None (open label)
- Enrolment
- 1,083 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ari Moskowitz, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520762
- Sponsor's protocol ID
- 2021-13691
- Other IDs
- R33HL162980
- Acronym
- HART
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial will be shared through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), in accordance with NHLBI data sharing policy. More detailed data may be made available on request for collaboration, peer review, or other appropriate purposes. All sharing will comply with applicable patient confidentiality regulations. Resource Sharing: Key resources, including methodologies and statistical practices, will be made available in the form of peer-reviewed publications during the trial period. The HART investigators will additionally be open to queries from other investigators regarding elements of the trial.
Publications
Holmberg MJ, Ross CE, Fitzmaurice GM, Chan PS, Duval-Arnould J, Grossestreuer AV, Yankama T, Donnino MW, Andersen LW; American Heart Association's Get With The Guidelines-Resuscitation Investigators. Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the United States. Circ Cardiovasc Qual Outcomes. 2019 Jul 9;12(7):e005580.
PubMed 31545574Coute RA, Panchal AR, Mader TJ, Neumar RW. National Institutes of Health-Funded Cardiac Arrest Research: A 10-Year Trend Analysis. J Am Heart Assoc. 2017 Jul 12;6(7):e005239. doi: 10.1161/JAHA.116.005239.
PubMed 28701308Sinha SS, Sukul D, Lazarus JJ, Polavarapu V, Chan PS, Neumar RW, Nallamothu BK. Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):749-756. doi: 10.1161/CIRCOUTCOMES.116.002916. Epub 2016 Oct 18.
PubMed 27756794Wang HE, Kupas DF, Greenwood MJ, Pinchalk ME, Mullins T, Gluckman W, Sweeney TA, Hostler D. An algorithmic approach to prehospital airway management. Prehosp Emerg Care. 2005 Apr-Jun;9(2):145-55. doi: 10.1080/10903120590924618.
PubMed 16036838Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
PubMed 33081529Bradley SM, Zhou Y, Ramachandran SK, Engoren M, Donnino M, Girotra S. 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. Crit Care. 2019 May 6;23(1):158. doi: 10.1186/s13054-019-2426-5.
PubMed 31060580Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
PubMed 30167699Moskowitz A, Holmberg MJ, Donnino MW, Berg KM. In-hospital cardiac arrest: are we overlooking a key distinction? Curr Opin Crit Care. 2018 Jun;24(3):151-157. doi: 10.1097/MCC.0000000000000505.
PubMed 29688939Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
PubMed 34762729Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP.
PubMed 31034248Schoenfeld DA, Bernard GR; ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002 Aug;30(8):1772-7. doi: 10.1097/00003246-200208000-00016.
PubMed 12163791Witten L, Gardner R, Holmberg MJ, Wiberg S, Moskowitz A, Mehta S, Grossestreuer AV, Yankama T, Donnino MW, Berg KM. Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest. Resuscitation. 2019 Mar;136:93-99. doi: 10.1016/j.resuscitation.2019.01.031. Epub 2019 Jan 30.
PubMed 30710595Haywood K, Whitehead L, Nadkarni VM, Achana F, Beesems S, Bottiger BW, Brooks A, Castren M, Ong MEH, Hazinski MF, Koster RW, Lilja G, Long J, Monsieurs KG, Morley PT, Morrison L, Nichol G, Oriolo V, Saposnik G, Smyth M, Spearpoint K, Williams B, Perkins GD; COSCA Collaborators. COSCA (Core Outcome Set for Cardiac Arrest) in Adults: An Advisory Statement From the International Liaison Committee on Resuscitation. Resuscitation. 2018 Jun;127:147-163. doi: 10.1016/j.resuscitation.2018.03.022. Epub 2018 Apr 26.
PubMed 29706235Hemming K, Kasza J, Hooper R, Forbes A, Taljaard M. A tutorial on sample size calculation for multiple-period cluster randomized parallel, cross-over and stepped-wedge trials using the Shiny CRT Calculator. Int J Epidemiol. 2020 Jun 1;49(3):979-995. doi: 10.1093/ije/dyz237.
PubMed 32087011Sevransky JE, Rothman RE, Hager DN, Bernard GR, Brown SM, Buchman TG, Busse LW, Coopersmith CM, DeWilde C, Ely EW, Eyzaguirre LM, Fowler AA, Gaieski DF, Gong MN, Hall A, Hinson JS, Hooper MH, Kelen GD, Khan A, Levine MA, Lewis RJ, Lindsell CJ, Marlin JS, McGlothlin A, Moore BL, Nugent KL, Nwosu S, Polito CC, Rice TW, Ricketts EP, Rudolph CC, Sanfilippo F, Viele K, Martin GS, Wright DW; VICTAS Investigators. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):742-750. doi: 10.1001/jama.2020.24505.
PubMed 33620405
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial
- ClinicalTrials.gov ID
- NCT05520762
- Acronym / sponsor ID
- HART / 2021-13691
- Conditions
- Cardiac Arrest, Respiratory Failure
- Keywords
- Cardiac Arrest, Emergency Airway Management, In-hospital Cardiac Arrest, Endotracheal Intubation, Supraglottic Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,083 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized design with crossover
| Arm | Type | Receives |
|---|---|---|
| First choice supraglottic airway device, Then First choice endotracheal intubation | Experimental | Procedure: A strategy of first choice supraglottic airway, Procedure: A strategy of first choice endotracheal intubationA 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. |
| First choice endotracheal intubation, Then First choice supraglottic airway | Active comparator | Procedure: A strategy of first choice supraglottic airway, Procedure: A strategy of first choice endotracheal intubationA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Cardiac arrest in the Operating Room or other area not responded to by Critical Care/Emergency Department (ED) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A strategy of first choice supraglottic airwaySee description in Arms section | Procedure or surgery | First choice endotracheal intubation, Then First choice supraglottic airway, First choice supraglottic airway device, Then First choice endotracheal intubation |
| A strategy of first choice endotracheal intubationSee description in Arms section | Procedure or surgery | First choice endotracheal intubation, Then First choice supraglottic airway, First choice supraglottic airway device, Then First choice endotracheal intubation |
Primary outcome
Alive-and-ventilator free days
Time frame: From cardiac arrest until 28-days after cardiac arrest
The number of days a patient is alive and breathing independently of invasive mechanical ventilation will be summarized by study arm using basic descriptive statistics. A patient who leaves the hospital alive and is not discharged to a hospice setting, will be considered to have lived to 28-days. A patient discharged to a hospice facility will be assessed as having died on the day of hospital discharge. A patient who is discharged on invasive mechanical ventilation, will be assumed to have remained on invasive mechanical ventilation through 28-days.
5 secondary outcomes
Return of spontaneous circulation (ROSC)
Time frame: Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours
72 hour survival
Time frame: From IHCA event until 72 hours after IHCA event
28 day survival
Time frame: From IHCA event until 28 days after IHCA event
Functional Outcome at Discharge
Time frame: Time of hospital discharge
Survival to hospital discharge
Time frame: From IHCA event until 60 days after cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 31545574Holmberg MJ, Ross CE, Fitzmaurice GM, Chan PS, Duval-Arnould J, Grossestreuer AV, Yankama T, Donnino MW, Andersen LW; American Heart Association's Get With The Guidelines-Resuscitation Investigators. Annual Incidence of Adult and Pediatric In-Hospital Cardiac Arrest in the United States. Circ Cardiovasc Qual Outcomes. 2019 Jul 9;12(7):e005580.
- Background: PubMed 28701308Coute RA, Panchal AR, Mader TJ, Neumar RW. National Institutes of Health-Funded Cardiac Arrest Research: A 10-Year Trend Analysis. J Am Heart Assoc. 2017 Jul 12;6(7):e005239. doi: 10.1161/JAHA.116.005239.
- Background: PubMed 27756794Sinha SS, Sukul D, Lazarus JJ, Polavarapu V, Chan PS, Neumar RW, Nallamothu BK. Identifying Important Gaps in Randomized Controlled Trials of Adult Cardiac Arrest Treatments: A Systematic Review of the Published Literature. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):749-756. doi: 10.1161/CIRCOUTCOMES.116.002916. Epub 2016 Oct 18.
- Background: PubMed 16036838Wang HE, Kupas DF, Greenwood MJ, Pinchalk ME, Mullins T, Gluckman W, Sweeney TA, Hostler D. An algorithmic approach to prehospital airway management. Prehosp Emerg Care. 2005 Apr-Jun;9(2):145-55. doi: 10.1080/10903120590924618.
- Background: PubMed 33081529Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 31060580Bradley SM, Zhou Y, Ramachandran SK, Engoren M, Donnino M, Girotra S. 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. Crit Care. 2019 May 6;23(1):158. doi: 10.1186/s13054-019-2426-5.
- Background: PubMed 30167699Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.
- Background: PubMed 29688939Moskowitz A, Holmberg MJ, Donnino MW, Berg KM. In-hospital cardiac arrest: are we overlooking a key distinction? Curr Opin Crit Care. 2018 Jun;24(3):151-157. doi: 10.1097/MCC.0000000000000505.
- Background: PubMed 34762729Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
- Background: PubMed 31034248Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP.
- Background: PubMed 12163791Schoenfeld DA, Bernard GR; ARDS Network. Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med. 2002 Aug;30(8):1772-7. doi: 10.1097/00003246-200208000-00016.
- Background: PubMed 30710595Witten L, Gardner R, Holmberg MJ, Wiberg S, Moskowitz A, Mehta S, Grossestreuer AV, Yankama T, Donnino MW, Berg KM. Reasons for death in patients successfully resuscitated from out-of-hospital and in-hospital cardiac arrest. Resuscitation. 2019 Mar;136:93-99. doi: 10.1016/j.resuscitation.2019.01.031. Epub 2019 Jan 30.
- International Committee of Medical Journal Editors. Defining the Role of Authors and Contributors. Accessed July 6, 2017.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial will be shared through the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC), in accordance with NHLBI data sharing policy. More detailed data may be made available on request for collaboration, peer review, or other appropriate purposes. All sharing will comply with applicable patient confidentiality regulations. Resource Sharing: Key resources, including methodologies and statistical practices, will be made available in the form of peer-reviewed publications during the trial period. The HART investigators will additionally be open to queries from other investigators regarding elements of the trial.
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Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Moskowitz, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A strategy of first choice supraglottic airway and A strategy of first choice endotracheal intubation in people with Cardiac Arrest and Respiratory Failure, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive-and-ventilator free days (time frame: From cardiac arrest until 28-days after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520762, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.