Hospital Airway Resuscitation Trial

Официальное название

Hospital Airway Resuscitation Trial: A Cluster-Randomized, Pragmatic Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура A strategy of first choice supraglottic airway
  See description in Arms section
• Процедура A strategy of first choice endotracheal intubation
  See description in Arms section

Первичные конечные точки

• Alive-and-ventilator free days [Срок оценки: From cardiac arrest until 28-days after cardiac arrest]

Вторичные конечные точки (5)

• Return of spontaneous circulation (ROSC) [Срок оценки: Onset of in-hospital cardiac arrest event until either ROSC or death up to 24 hours]
• 72 hour survival [Срок оценки: From IHCA event until 72 hours after IHCA event]
• 28 day survival [Срок оценки: From IHCA event until 28 days after IHCA event]
• Functional Outcome at Discharge [Срок оценки: Time of hospital discharge]
• Survival to hospital discharge [Срок оценки: From IHCA event until 60 days after cardiac arrest]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Montefiore Medical Center — New York

Публикации

• 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
• 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. PMID 28701308
• Sinha 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. PMID 27756794
• 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
• 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 PMID 33081529
• 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
• 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 Ra PMID 30167699
• 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

Идентификаторы

NCT: NCT05520762 · 2021-13691 · R33HL162980

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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