Effect of early nasal cooling on survival after cardiac arrest
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1022 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 11 sites (Vienna and 10 other locations) |
| Trial ID | NCT06025123 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 who have experienced an out-of-hospital cardiac arrest with an initial shockable rhythm.
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.
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 performed: While the approach of transnasal cooling is innovative, similar studies have shown promise in improving outcomes after cardiac arrest.
Eligibility criteria
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 this trial is running
Vienna and 10 other locations
- University Hospital Vienna — Vienna, Austria (Not_yet_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)
- Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Not_yet_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)
Study contacts
- Principal investigator: Per Nordberg, MD, PhD — Karolinska Institutet
- Study coordinator: Per Nordberg, MD, PhD
- Email: per.nordberg@ki.se
- Phone: +46702802579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.