Early transnasal evaporative cooling with the RhinoChill device
DeviceEarly prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours
Recruiting
NCT Number: NCT06025123
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
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)).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–79 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University Hospital Vienna, Vienna, Austria
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients ≥18 years that meet all of the following inclusion criteria:
- Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
- Unconsciousness defined as Glasgow Coma Scale < 8
- Inclusion within 20 minutes from EMS arrival
Exclusion criteria
Patients are not eligible if they meet one or more of the following criteria:
- Age ≥ 80 years
- Obvious non-cardiac causes to cardiac arrest
- Obvious already hypothermic
- Obvious barrier to placing intra nasal catheters
- Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
- Have a known terminal disease
- Known or clinically apparent pregnancy
Treatment and study plan
Primary outcomes
-
Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.
Time frame: Day 90
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
Secondary outcomes
-
Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital
Time frame: Day 1
-
Proportion of patients alive at hospital discharge
Time frame: Day 1-90
-
Proportion of patients with Modified Rankin scale 0-3 at hospital discharge
Time frame: Day 1-90
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
-
Proportion of patients alive at 90 days
Time frame: Day 90
-
Proportion of patients with Modified Rankin scale 0-3 at 90 days
Time frame: Day 90
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
-
Device related adverse event rate within the first 24 hours
Time frame: Day 1
Safety
-
Composite serious adverse event rate within the first 7 days
Time frame: Day 1-7
Safety
-
Proportion of patients with new cardiac arrest prior to hospital admission
Time frame: Day 1
Safety
Other outcomes
-
Hospital-free days alive at 90 days
Time frame: Day 90
-
Distribution of modified Rankin scale at 90 days
Time frame: Day 90
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
-
Distribution of Cerebral Performance Category scale at 90 days
Time frame: Day 90
The Cerebral Performance Category (CPC) scale is a measure for neurologic function. It ranges from 1-5, where 1 equals no or minimal neurologic disabilities, and 5 equals death.
-
Proportion of patients alive after 1 year
Time frame: Day 365
-
Proportion of patients with Modified Rankin scale 0-1 at 1 year
Time frame: Day 365
The modified Rankin Scale is a scoring system on neurologic function ranging from 0-6, where 0 means no symtoms at all, higher numbers indicating increasing neurologic disabilities and 6 equals death.
-
Quality of life assessed with EQ-5D-5L at 90 days
Time frame: Day 90
EQ-5D is a a measure of health status and quality of life defined in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three levels; no problems, some or moderate problems or extreme problems.
Study contacts
Contact information is provided by the study sponsor or research team.
Emelie Dillenbeck, MD
CONTACT
Per Nordberg, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Karolinska Institutet
Other
Registry information
Official study title
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
Acronym: PRINCESS2
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Sep 6, 2023
- Registry last updated
- Sep 25, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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