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)).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,022
Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours
Medizinische Universität Graz, Abteilung für Kardiologie
Graz, Austria
RECRUITINGUniversity Hospital Vienna
Vienna, Austria
RECRUITINGCHU Saint-Pierre
Brussels, Belgium
RECRUITINGErasme University Hospital
Brussels, Belgium
RECRUITINGEurope Hospitals St Elizabeth
Brussels, Belgium
RECRUITINGKlinikum Bamberg (Sozialstiftung Bamberg).
Bamberg, Germany
NOT_YET_RECRUITINGUniversity Hospital Freiburg
Freiburg im Breisgau, Germany
RECRUITINGChristliches Klinikum Halle
Halle, Germany
RECRUITINGUniversitätsklinikum Halle
Halle, Germany
RECRUITINGAsklepios Südpfalzklinik
Kandel, Germany
RECRUITING...and 7 more locations
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
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