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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)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early transnasal evaporative cooling with the RhinoChill device | Experimental | Early transnasal evaporative cooling initiated during ACLS at the scene of the cardiac arrest within 20 minutes from EMS arrival and subsequent hypothermia at 33ºC for 24 hours and fever control for 72 hours at the ICU |
|
| Standard of care | No Intervention | Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early transnasal evaporative cooling with the RhinoChill device | Device | Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1. | The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death. | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital | Day 1 | |
| Proportion of patients alive at hospital discharge | Day 1-90 | |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-free days alive at 90 days | Day 90 | |
| Distribution of modified Rankin scale at 90 days | The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death. |
INCLUSION CRITERIA:
Patients ≥18 years that meet all of the following inclusion criteria:
EXCLUSION CRITERIA:
Patients are not eligible if they meet one or more of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per Nordberg, MD, PhD | Contact | +46702802579 | per.nordberg@ki.se | |
| Emelie Dillenbeck, MD | Contact | +46736484567 | emelie.dillenbeck@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Per Nordberg, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Vienna | Not yet recruiting | Vienna | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41680915 | Derived | 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 results from the PRINCESS2 randomised trial. Crit Care. 2026 Feb 12;30(1):93. doi: 10.1186/s13054-026-05851-y. | |
| 38417773 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2023 | Nov 6, 2023 |
Patients will be randomized by EMS personnel at the scene of cardiac arrest to either a) intervention: early transnasal evaporative cooling initiated within 20 minutes from EMS arrival, and subsequent systemic hypothermia at 33°C for 24 h and fever control for 72 h in the ICU, or b) control: standard ACLS (advanced cardiac life support) and fever control (normothermia) for 72 h in the ICU.
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Patients in the intervention group will be treated with hypothermia, which makes blinding for care provider and next of kin difficult in the intervention phase (first 36 h). Participants will be informed of which group the were assigned to if they regained consciousness. The study personnel assessing neurologic outcome at discharge and at 90 days will be blinded for which study group the participant belongs to. In addition, the physician performing the prognostication at 72 hours from cardiac arrest will be a neurologist, intensivist or other specialist experienced and will be blinded for group allocation, but not for relevant clinical data.
| Proportion of patients with Modified Rankin scale 0-3 at hospital discharge |
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death. |
| Day 1-90 |
| Proportion of patients alive at 90 days | Day 90 |
| Proportion of patients with Modified Rankin scale 0-3 at 90 days | The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death. | Day 90 |
| Device related adverse event rate within the first 24 hours | Safety | Day 1 |
| Composite serious adverse event rate within the first 7 days | Safety | Day 1-7 |
| Proportion of patients with new cardiac arrest prior to hospital admission | Safety | Day 1 |
| Day 90 |
| Distribution of Cerebral Performance Category scale at 90 days | The Cerebral Performance Category (CPC) scale is a measure for neurologic function. It ranges from 1-5, where 1 equals no or minimal neurologic disabilities, and 5 equals death. | Day 90 |
| Proportion of patients alive after 1 year | Day 365 |
| Proportion of patients with Modified Rankin scale 0-1 at 1 year | The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death. | Day 365 |
| Quality of life assessed with EQ-5D-5L at 90 days | EQ-5D is a a measure of health status and quality of life defined in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels; no problems, some or moderate problems or extreme problems. | Day 90 |
| CHU Saint-Pierre | Recruiting | Brussels | Belgium |
|
| Erasme University Hospital | Recruiting | Brussels | Belgium |
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| Europe Hospitals St Elizabeth | Recruiting | Brussels | Belgium |
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| University Hospital Freiburg | Recruiting | Freiburg im Breisgau | Germany |
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| Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Not yet recruiting | Milan | Italy |
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| Ljubljana University Medical Centre | Recruiting | Ljubljana | Slovenia |
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| Hospital Universitario La Paz | Recruiting | Madrid | Spain |
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| San Carlos Clinical Hospital | Recruiting | Madrid | Spain |
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| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
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| Södersjukhuset | Recruiting | Stockholm | Sweden |
|
| Derived |
| 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 arrest with initial shockable rhythm. Am Heart J. 2024 May;271:97-108. doi: 10.1016/j.ahj.2024.02.020. Epub 2024 Feb 28. |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2023 | Nov 6, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D007035 | Hypothermia |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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