Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Официальное название

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Обзор

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm. The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia. Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).

Вмешательства

• Устройство Early transnasal evaporative cooling with the RhinoChill device
  Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours

Первичные конечные точки

• Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1. [Срок оценки: Day 90]

Вторичные конечные точки (8)

• Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital [Срок оценки: Day 1]
• Proportion of patients alive at hospital discharge [Срок оценки: Day 1-90]
• Proportion of patients with Modified Rankin scale 0-3 at hospital discharge [Срок оценки: Day 1-90]
• Proportion of patients alive at 90 days [Срок оценки: Day 90]
• Proportion of patients with Modified Rankin scale 0-3 at 90 days [Срок оценки: Day 90]
• Device related adverse event rate within the first 24 hours [Срок оценки: Day 1]
• Composite serious adverse event rate within the first 7 days [Срок оценки: Day 1-7]
• Proportion of patients with new cardiac arrest prior to hospital admission [Срок оценки: Day 1]

Критерии участия

Критерии включения

Patients ≥18 years that meet all of the following inclusion criteria:

• Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
• Unconsciousness defined as Glasgow Coma Scale < 8
• Inclusion within 20 minutes from EMS arrival

Критерии исключения

Patients are not eligible if they meet one or more of the following criteria:

• Age ≥ 80 years
• Obvious non-cardiac causes to cardiac arrest
• Obvious already hypothermic
• Obvious barrier to placing intra nasal catheters
• Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
• Have a known terminal disease
• Known or clinically apparent pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 3 центра

• CHU Saint-Pierre — Brussels
• Erasme University Hospital — Brussels
• Europe Hospitals St Elizabeth — Brussels

Испания · 2 центра

• Hospital Universitario La Paz — Madrid
• San Carlos Clinical Hospital — Madrid

Швеция · 2 центра

• Karolinska University Hospital — Stockholm
• Södersjukhuset — Stockholm

Австрия · 1 центр

• University Hospital Vienna — Vienna

Германия · 1 центр

• University Hospital Freiburg — Freiburg im Breisgau

Италия · 1 центр

• Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Os — Milan

Словения · 1 центр

• Ljubljana University Medical Centre — Ljubljana

Публикации

• Dillenbeck E, Berthelsen T, Corral Torres E, Lopez-de-Sa E, Rosillo Rodriguez SO, Sanchez-Garcia M, Martin Benitez JC, Busch HJ, Radsel P, Ristagno G, Nichol G, Holzer M, Moreau A, Forsberg S, Backstrom D, Awad A, Taccone FS, Falk A, Hollenberg J, Jonsson M, Liliequist A, Jurga J, Okas M, Svensson L, Nordberg P. On-scene selective brain cooling in ventricular fibrillation cardiac arrest: pilot res PMID 41680915
• Dillenbeck E, Hollenberg J, Holzer M, Busch HJ, Nichol G, Radsel P, Belohlavec J, Torres EC, Lopez-de-Sa E, Rosell F, Ristagno G, Forsberg S, Annoni F, Svensson L, Jonsson M, Backstrom D, Gellerfors M, Awad A, Taccone FS, Nordberg P. The design of the PRINCESS 2 trial: A randomized trial to study the impact of ultrafast hypothermia on complete neurologic recovery after out-of-hospital cardiac arre PMID 38417773

Идентификаторы

NCT: NCT06025123 · 2022-02446-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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