Actively Recruiting
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Led by Karolinska Institutet · Updated on 2025-09-25
1022
Participants Needed
11
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)).
CONDITIONS
Official Title
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
- Unconsciousness with Glasgow Coma Scale less than 8
- Inclusion within 20 minutes from EMS arrival
You will not qualify if you...
- Age 80 years or older
- Obvious non-cardiac causes for cardiac arrest
- Obvious already hypothermic condition
- Obvious barrier to placing intranasal catheters
- Known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
- Known terminal disease
- Known or clinically apparent pregnancy
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Trial Site Locations
Total: 11 locations
1
University Hospital Vienna
Vienna, Austria
Not Yet Recruiting
2
CHU Saint-Pierre
Brussels, Belgium
Actively Recruiting
3
Erasme University Hospital
Brussels, Belgium
Actively Recruiting
4
Europe Hospitals St Elizabeth
Brussels, Belgium
Actively Recruiting
5
University Hospital Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
6
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Not Yet Recruiting
7
Ljubljana University Medical Centre
Ljubljana, Slovenia
Actively Recruiting
8
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
9
San Carlos Clinical Hospital
Madrid, Spain
Actively Recruiting
10
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
11
Södersjukhuset
Stockholm, Sweden
Actively Recruiting
Research Team
P
Per Nordberg, MD, PhD
CONTACT
E
Emelie Dillenbeck, MD
CONTACT
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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