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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Sponsor: Karolinska Institutet • ClinicalTrials.gov ID: NCT06025123

Registry updated: 2026-09-16

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Description

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)).

Interventions

Early transnasal evaporative cooling with the RhinoChill device (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

INCLUSION CRITERIA: Patients ≥18 years that meet all of the following inclusion criteria: 1. Adult out-of-hospital cardiac arrest patients with initial shockable rhythm 2. Unconsciousness defined as Glasgow Coma Scale \< 8 3. Inclusion within 20 minutes from EMS arrival EXCLUSION CRITERIA: Patients are not eligible if they meet one or more of the following 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

Conditions

Out-Of-Hospital Cardiac Arrest Hypothermia Ventricular Fibrillation

Locations

Medizinische Universität Graz, Abteilung für Kardiologie — Graz, Austria
University Hospital Vienna — Vienna, Austria
CHU Saint-Pierre — Brussels, Belgium
Erasme University Hospital — Brussels, Belgium
Europe Hospitals St Elizabeth — Brussels, Belgium
Klinikum Bamberg (Sozialstiftung Bamberg). — Bamberg, Germany
University Hospital Freiburg — Freiburg im Breisgau, Germany
Christliches Klinikum Halle — Halle, Germany
Universitätsklinikum Halle — Halle, Germany
Asklepios Südpfalzklinik — Kandel, Germany
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy
Ullevål hospital — Oslo, Norway
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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