Trials / Recruiting
RecruitingNCT06025123
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,022 (estimated)
- Sponsor
- Karolinska Institutet · Academic / Other
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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)).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Early 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 |
Timeline
- Start date
- 2024-03-27
- Primary completion
- 2028-02-01
- Completion
- 2028-05-01
- First posted
- 2023-09-06
- Last updated
- 2025-09-25
Locations
11 sites across 7 countries: Austria, Belgium, Germany, Italy, Slovenia, Spain, Sweden
Source: ClinicalTrials.gov record NCT06025123. Inclusion in this directory is not an endorsement.