Nordberg 2013.

Trial name or title	Pre‐hospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study (PRINCESS)
Methods	Randomized, controlled, open‐label, parallel design, phase 2 study
Participants	Participants with out‐of‐hospital cardiac arrest Inclusion criteria: Age ≥ 18 years Collapse was witnessed (heard or seen) Do not have a pulse Are unresponsive to external stimuli Exclusion criteria: Age ≥ 80 years Have an aetiology of cardiac arrest due to trauma, severe bleeding, drug overdose, cerebrovascular accident, drowning, smoke inhalation, electrocution, hanging Already hypothermic (e.g. avalanche victim; found in the snow) Have an obvious barrier to placing intra nasal catheters (e.g. intranasal obstruction) Do Not Attempt to Resuscitate (DNAR) orders Have a terminal disease Known or clinically apparent pregnancy Have a known coagulopathy (except therapeutically induced) Are known to have a need for supplemental oxygen Achieve ROSC prior to randomization Response time (call to arrival) of the ambulance > 15 minutes
Interventions	No intervention: control participants in the control group standard advanced cardiac life support care. Participants that achieve return of spontaneous circulation will be treated with cooling according to current guidelines upon arrival at the intensive care unit. Experimental intervention: intra‐arrest transnasal cooling with RhinoChill will be initiated during advanced cardiac life support. In participants achieving return of spontaneous circulation, transnasal cooling will continue until systemic cooling is started at the intensive care unit. Intervention: Device: pre‐hospital intranasal cooling with RhinoChill
Outcomes	Primary: Neurologically intact survival (CPC ‐ cerebral performance categories scale 1 to 2) (time frame: 90 days after cardiac arrest) Secondary: Total survival (time frame: 90 days) (designated as safety issue: no) Proportion of participants achieving return of spontaneous circulation (ROSC) (time frame: 1 hour) (designated as safety issue: no) Time to target temperature of 32°C to 34°C (time frame: 8 to 10 hours) (designated as safety issue: no) Admitted alive to hospital (time frame: 2 to 4 hours) (designated as safety issue: no); proportion of participants that are admitted alive to hospital
Starting date	June 2010
Contact information	Leif Svensson, MD, PhD, leif.svensson@sodersjukhuset.se Maaret Castrén, MD, PhD, maaret.castren@sodersjukhuset.se
Notes	This study is currently recruiting participants

CPC = cerebral performance categories
 DNAR = do not attempt resuscitation
 ROSC = return of spontaneous circulation