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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 79 Years |
| Sex | All |
| Enrollment | 1022 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 17 sites (Graz and 16 other locations) |
| Status | Recruiting |
| Started | March 27, 2024 |
| Main results expected | February 2028 |
| Study ends | May 2028 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT06025123 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.
-
Early double sequential defibrillation for cardiac arrest outside the hospital
We test whether using two defibrillators in quick succession after the first failed shock helps adults with out‑of‑hospital cardiac arrest and a shockable rhythm survive more often than continuing standard single shocks.
-
Initial double sequential defibrillation for out-of-hospital ventricular fibrillation
This trial will test whether using two defibrillators to give double sequential shocks first improves survival for adults with out-of-hospital cardiac arrest and a shockable rhythm.
-
Assessing the benefits of ICD implantation in patients with coronary artery disease after cardiac arrest
This study is testing if getting an implantable defibrillator helps people with coronary artery disease who have survived a cardiac arrest feel better and live longer.
-
Minimal Sedation After Out-of-Hospital Cardiac Arrest
This study tests whether stopping continuous sedation right after return of circulation is as safe as keeping patients sedated in the early hours after OHCA.
-
Acupressure to reduce feverish shivering after cesarean delivery
This study tests whether applying acupressure around the time of cesarean delivery can help prevent hypothermia and shivering in healthy-looking, first-time cesarean patients.
-
Risk of malignant arrhythmias after acute coronary syndrome
This study tracks how often dangerous heart rhythms occur in adults admitted for ACS and looks for patterns that might predict them.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.