An interventional study of Early transnasal evaporative cooling with the RhinoChill device in Out-Of-Hospital Cardiac Arrest, Hypothermia and Ventricular Fibrillation, sponsored by Karolinska Institutet. Recruiting at 17 sites in 8 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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)).
314 studies on the registry are indexed under Out-of-Hospital Cardiac Arrest; 93 are open to participants now.
This study's planned enrollment of 1,022 is above the median of 218 across 179 interventional studies indexed under Out-of-Hospital Cardiac Arrest.
Browse Out-of-Hospital Cardiac Arrest studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
Device: Early transnasal evaporative cooling with the RhinoChill device
Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU
Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours
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.
Time frame: Day 90
Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital
Time frame: Day 1
Proportion of patients alive at hospital discharge
Time frame: Day 1-90
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.
Time frame: Day 1-90
Proportion of patients alive at 90 days
Time frame: 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.
Time frame: Day 90
Device related adverse event rate within the first 24 hours
Safety
Time frame: Day 1
Composite serious adverse event rate within the first 7 days
Safety
Time frame: Day 1-7
Proportion of patients with new cardiac arrest prior to hospital admission
Safety
Time frame: Day 1
Hospital-free days alive at 90 days
Time frame: 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.
Time frame: 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.
Time frame: Day 90
Proportion of patients alive after 1 year
Time frame: 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.
Time frame: 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.
Time frame: Day 90
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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