Clinical trial Recruiting at 15 sites Interventional Ages 18 to 79

Effect of early nasal cooling on survival after cardiac arrest

Official title: Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Run by Karolinska Institutet · NCT06025123 · Data updated 2026-11-12

This study is testing if cooling patients right after a cardiac arrest can help them survive better and recover their brain function compared to standard care.

More Out-Of-Hospital Cardiac Arrest trials

Quick facts

Study typeInterventional
Ages18 Years to 79 Years
SexAll
Enrollment1022 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations17 sites (Graz and 16 other locations)
StatusRecruiting
StartedMarch 27, 2024
Main results expectedFebruary 2028
Study endsMay 2028
Registry record updatedSeptember 16, 2026
Trial IDNCT06025123 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-79 who have experienced an out-of-hospital cardiac arrest with an initial shockable rhythm.

Probably not a fit

Patients aged 80 and older, those with non-cardiac causes of arrest, or those with existing hypothermia will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of ultra-early transnasal evaporative cooling in patients who have experienced out-of-hospital cardiac arrest with an initial shockable rhythm. Participants will be randomized into two groups: one receiving immediate cooling treatment initiated by EMS personnel, and the other receiving standard normothermia. The primary outcome is to assess the difference in survival rates with complete neurologic recovery at 90 days post-arrest between the two groups. The study aims to determine if early cooling can improve outcomes compared to conventional treatment.

Why it matters

Potential benefit: If successful, this approach could significantly enhance survival rates and neurologic recovery in patients who suffer cardiac arrest.

How similar studies have gone: While the approach of transnasal cooling is innovative, similar studies have shown promise in improving outcomes after cardiac arrest.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Medizinische Universität Graz, Abteilung für Kardiologie
    Graz, Austria
    Recruiting
  • University Hospital Vienna
    Vienna, Austria
    Recruiting
  • CHU Saint-Pierre
    Brussels, Belgium
    Recruiting
  • Erasme University Hospital
    Brussels, Belgium
    Recruiting
  • Europe Hospitals St Elizabeth
    Brussels, Belgium
    Recruiting
  • University Hospital Freiburg
    Freiburg im Breisgau, Germany
    Recruiting
Show 11 more locations
  • Christliches Klinikum Halle
    Halle, Germany
    Recruiting
  • Universitätsklinikum Halle
    Halle, Germany
    Recruiting
  • Asklepios Südpfalzklinik
    Kandel, Germany
    Recruiting
  • Ullevål hospital
    Oslo, Norway
    Recruiting
  • Ljubljana University Medical Centre
    Ljubljana, Slovenia
    Recruiting
  • Hospital Universitario La Paz
    Madrid, Spain
    Recruiting
  • San Carlos Clinical Hospital
    Madrid, Spain
    Recruiting
  • Karolinska University Hospital
    Stockholm, Sweden
    Recruiting
  • Södersjukhuset
    Stockholm, Sweden
    Recruiting
  • Klinikum Bamberg (Sozialstiftung Bamberg).
    Bamberg, Germany
    Not yet recruiting
  • Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, Italy
    Not yet recruiting

Study contacts

  • Principal investigator: Per Nordberg, MD, PhD — Karolinska Institutet
  • Study coordinator: Per Nordberg, MD, PhD
  • Email: per.nordberg@ki.se
  • Phone: +46702802579

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.