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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

RecruitingNAAges 18 Years - 79 YearsAllKarolinska Institutet
NCT06025123 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 hypothe

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📋 Eligibility rules (as published)
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
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What it tests

  • Early transnasal evaporative cooling with the RhinoChill device
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Where

17 sites
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

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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