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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Sponsor: Karolinska Institutet
Summary
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)).
Official title: Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
1022
Start Date
2024-03-27
Completion Date
2028-05
Last Updated
2025-09-25
Healthy Volunteers
No
Interventions
Early transnasal evaporative cooling with the RhinoChill device
Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours
Locations (11)
University Hospital Vienna
Vienna, Austria
CHU Saint-Pierre
Brussels, Belgium
Erasme University Hospital
Brussels, Belgium
Europe Hospitals St Elizabeth
Brussels, Belgium
University Hospital Freiburg
Freiburg im Breisgau, Germany
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Ljubljana University Medical Centre
Ljubljana, Slovenia
Hospital Universitario La Paz
Madrid, Spain
San Carlos Clinical Hospital
Madrid, Spain
Karolinska University Hospital
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden