RecruitingNot ApplicableNCT06025123

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)


Sponsor

Karolinska Institutet

Enrollment

1,022 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Early transnasal evaporative cooling with the RhinoChill device for people with hypothermia, out-of-hospital cardiac arrest, and other related conditions. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEarly 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(17)

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

View Full Details on ClinicalTrials.gov

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NCT06025123


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