On-scene selective brain cooling in ventricular fibrillation cardiac arrest: pilot results from the PRINCESS2 randomised trial.
Emelie Dillenbeck, Thomas Berthelsen, Ervigio Corral Torres...
https://pubmed.ncbi.nlm.nih.gov/41680915Actively Recruiting
Phase Not Applicable
Age: 18Years - 79Years
All Genders
ID06025123
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
Led by Karolinska Institutet · Updated on 2025-09-25
1022
Participants Needed
11
Research Sites
12 weeks
Total Duration
On this page
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 33°C 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
Who Can Participate
Age: 18Years - 79Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
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
Loading map...
Research Team
P
Per Nordberg, MD, PhD
E
Emelie Dillenbeck, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
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...
https://pubmed.ncbi.nlm.nih.gov/38417773