Hospital Airway Resuscitation Trial

NCT05520762 | Recruiting DMC

• 2 other identifiers: 2021-13691R33HL162980
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Arrest; Respiratory Failure

Keywords

Cardiac Arrest; Emergency Airway Management; In-hospital Cardiac Arrest; Endotracheal Intubation; Supraglottic Airway

Outcome Measures

Primary Outcomes (1)

• 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.

  From cardiac arrest until 28-days after cardiac arrest

Secondary Outcomes (5)

• Return of spontaneous circulation (ROSC)

  Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours

• 72 hour survival

  From IHCA event until 72 hours after IHCA event

• 28 day survival

  From IHCA event until 28 days after IHCA event

• Functional Outcome at Discharge

  Time of hospital discharge

• Survival to hospital discharge

  From IHCA event until 60 days after cardiac arrest

Other Outcomes (7)

• Prolonged pauses

  From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours

• Rate of ventilator-associated pneumonia (VAP)

  Cardiac arrest until 7 days after cardiac arrest

• Chest compression fraction

  From start of chest compressions during cardiac arrest until ROSC or death up to 24-hours

Study Arms (2)

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.

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.

Procedure: A strategy of first choice supraglottic airway; Procedure: A strategy of first choice endotracheal intubation

Interventions

A strategy of first choice supraglottic airway PROCEDURE

See description in Arms section

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 intubation PROCEDURE

See description in Arms section

First choice endotracheal intubation, Then First choice supraglottic airway; First choice supraglottic airway device, Then First choice endotracheal intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Related Publications (28)

• 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.

  PMID: 31545574 BACKGROUND

• Coute 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.

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  PMID: 27756794 BACKGROUND

• Wang 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.

  PMID: 16036838 BACKGROUND

• Panchal 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.

  PMID: 33081529 BACKGROUND

• Bradley 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.

  PMID: 31060580 BACKGROUND

• Wang 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.

  PMID: 30167699 BACKGROUND

• Moskowitz 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.

  PMID: 29688939 BACKGROUND

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  PMID: 34762729 BACKGROUND

• Yehya 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.

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• Schoenfeld 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.

  PMID: 12163791 BACKGROUND

• Witten 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.

  PMID: 30710595 BACKGROUND

• Haywood 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.

  PMID: 29706235 BACKGROUND

• Hemming 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.

  PMID: 32087011 BACKGROUND

• Sevransky 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.

  PMID: 33620405 BACKGROUND

• Nichol G, Brown SP, Perkins GD, Kim F, Sterz F, Broeckel Elrod JA, Mentzelopoulos S, Lyon R, Arabi Y, Castren M, Larsen P, Valenzuela T, Graesner JT, Youngquist S, Khunkhlai N, Wang HE, Ondrej F, Sastrias JM, Barasa A, Sayre MR. What change in outcomes after cardiac arrest is necessary to change practice? Results of an international survey. Resuscitation. 2016 Oct;107:115-20. doi: 10.1016/j.resuscitation.2016.08.004. Epub 2016 Aug 23.

  PMID: 27565860 BACKGROUND

• Moskowitz A, Andrea L, Shiloh AL, Cardasis J, Carty C, Kim M, Xie X, McAllen S, Esses D, Lutz C, Takematsu M, Romero J, Schimmrich K, Fein DG, Dodi AE, Rednor S, Bangar M, Mohamed A, Eisen LA, Wang HE, Donnino MW, Gong MN. Design and implementation of the hospital airway resuscitation trial. Resusc Plus. 2023 Nov 30;17:100512. doi: 10.1016/j.resplu.2023.100512. eCollection 2024 Mar.

  PMID: 38076388 BACKGROUND

• Fein DG, Zhao D, Swartz K, Nauka P, Andrea L, Aboodi M, Shiloh AL, Eisen LA. The Impact of Nighttime on First Pass Success During the Emergent Endotracheal Intubation of Critically Ill Patients. J Intensive Care Med. 2021 Dec;36(12):1498-1506. doi: 10.1177/0885066620965166. Epub 2020 Oct 15.

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• Nauka PC, Chen JT, Shiloh AL, Eisen LA, Fein DG. Practice, Outcomes, and Complications of Emergent Endotracheal Intubation by Critical Care Practitioners During the COVID-19 Pandemic. Chest. 2021 Dec;160(6):2112-2122. doi: 10.1016/j.chest.2021.06.008. Epub 2021 Jun 15.

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• Janz DR, Semler MW, Lentz RJ, Matthews DT, Assad TR, Norman BC, Keriwala RD, Ferrell BA, Noto MJ, Shaver CM, Richmond BW, Zinggeler Berg J, Rice TW; Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU Investigators and the Pragmatic Critical Care Research Group. Randomized Trial of Video Laryngoscopy for Endotracheal Intubation of Critically Ill Adults. Crit Care Med. 2016 Nov;44(11):1980-1987. doi: 10.1097/CCM.0000000000001841.

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Related Links

• International Committee of Medical Journal Editors. Defining the Role of Authors and Contributors. Accessed July 6, 2017.

MeSH Terms

Conditions

Heart Arrest; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ari Moskowitz, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari Moskowitz, MD

CONTACT

718-920-5440; amoskowitz@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster-randomized design with crossover

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 30, 2022
• Study Start: February 10, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)