Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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)).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

⁃ Patients ≥18 years that meet all of the following inclusion criteria:

• Adult out-of-hospital cardiac arrest patients with initial shockable rhythm

• Unconsciousness defined as Glasgow Coma Scale \< 8

• Inclusion within 20 minutes from EMS arrival

Locations
Other Locations
Austria
University Hospital Vienna
NOT_YET_RECRUITING
Vienna
Belgium
CHU Saint-Pierre
RECRUITING
Brussels
Erasme University Hospital
RECRUITING
Brussels
Europe Hospitals St Elizabeth
RECRUITING
Brussels
Germany
University Hospital Freiburg
RECRUITING
Freiburg Im Breisgau
Italy
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Slovenia
Ljubljana University Medical Centre
RECRUITING
Ljubljana
Spain
Hospital Universitario La Paz
RECRUITING
Madrid
San Carlos Clinical Hospital
RECRUITING
Madrid
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Per Nordberg, MD, PhD
per.nordberg@ki.se
+46702802579
Backup
Emelie Dillenbeck, MD
emelie.dillenbeck@regionstockholm.se
+46736484567
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2028-05
Participants
Target number of participants: 1022
Treatments
Experimental: Early transnasal evaporative cooling with the RhinoChill device
Early transnasal evaporative cooling initiated during ACLS at the scene of the cardiac arrest within 20 minutes from EMS arrival and subsequent hypothermia at 33ºC for 24 hours and fever control for 72 hours at the ICU
No_intervention: Standard of care
Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov

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