Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
NCT ID: NCT06025123
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1022 participants
INTERVENTIONAL
2024-03-27
2028-05-31
Brief Summary
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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)).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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
Standard of care
Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Unconsciousness defined as Glasgow Coma Scale \< 8
3. Inclusion within 20 minutes from EMS arrival
Exclusion Criteria
1. Age ≥ 80 years
2. Obvious non-cardiac causes to cardiac arrest
3. Obvious already hypothermic
4. Obvious barrier to placing intra nasal catheters
5. Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
6. Have a known terminal disease
7. Known or clinically apparent pregnancy
18 Years
79 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Per Nordberg
Senior consultant in cardiology and intensive care, Associate Professor
Principal Investigators
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Per Nordberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Miguel Sanchez, PhD
Role: primary
Juan Carlos Martín Benítez, PhD
Role: backup
References
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Dillenbeck E, Hollenberg J, Holzer M, Busch HJ, Nichol G, Radsel P, Belohlavec J, Torres EC, Lopez-de-Sa E, Rosell F, Ristagno G, Forsberg S, Annoni F, Svensson L, Jonsson M, Backstrom D, Gellerfors M, Awad A, Taccone FS, Nordberg P. 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. Am Heart J. 2024 May;271:97-108. doi: 10.1016/j.ahj.2024.02.020. Epub 2024 Feb 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-02446-01
Identifier Type: -
Identifier Source: org_study_id
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