Study of Early Intranasal Cooling After Out-of-Hospital Cardiac Arrest Compared to Standard Treatment
For Adults Aged 18 to 79 Years With Shockable Heart Rhythm
Led by Karolinska Institutet · Updated on 2025-09-25
1022
Participants Needed
11
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of ultra-early transnasal evaporative cooling after cardiac arrest compared to the current recommended normothermia. This trial focuses on adults aged 18 to 79 who experienced out-of-hospital cardiac arrest with an initial shockable rhythm. The goal is to determine if early cooling improves survival with complete neurological recovery at 90 days post-arrest.
Participants are randomly assigned to one of two groups. The intervention group receives early transnasal evaporative cooling started by EMS personnel at the scene within 20 minutes of arrival, followed by systemic hypothermia at 33C for 24 hours and fever control for 72 hours in the ICU. The control group receives standard advanced cardiac life support and normothermia with fever control for 72 hours in the ICU.
During the study, researchers will monitor survival rates and neurological outcomes at 90 days using the modified Rankin scale. Secondary measures include return of spontaneous circulation, survival at hospital discharge, and adverse event rates. Participants will be closely observed from the time of cardiac arrest through hospital treatment and follow-up to assess the effectiveness and safety of the cooling treatment compared to standard care.
CONDITIONS
Brief Title
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Research Team
P
Per Nordberg, MD, PhD
E
Emelie Dillenbeck, MD
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Out-of-hospital cardiac arrest patients with initial shockable rhythm
Unconscious with Glasgow Coma Scale less than 8
Treatment can be started within 20 minutes of EMS arrival
You will not qualify if you...
Age 80 years or older
Cardiac arrest caused by obvious non-cardiac reasons
Already hypothermic before treatment
Physical barrier preventing placement of intranasal catheters
Known Do Not Attempt to Resuscitate (DNAR) order or care limitations
Known terminal disease
Known or apparent pregnancy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Up to 4 days
Participants receive early transnasal evaporative cooling initiated during advanced cardiac life support at the scene of cardiac arrest, followed by systemic hypothermia and fever control in the ICU.
Treatment begins within 20 minutes of EMS arrival and includes cooling for 24 hours and fever control for 72 hours in ICU
Follow-up
Duration - 90 days
Participants are monitored for survival and neurological recovery up to 90 days after treatment.
Assessments at hospital discharge and at 90 days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Emelie Dillenbeck, Jacob Hollenberg, Michael Holzer...