Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorKarolinska Institutet
About this trial
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)).
Eligibility criteria
Qualifiers
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
Disqualifiers
Age ≥ 80 years
Obvious non-cardiac causes to cardiac arrest
Obvious already hypothermic
Obvious barrier to placing intra nasal catheters
Trial design
Treatments tested in this trial
- Early transnasal evaporative cooling with the RhinoChill device
Treatment groups
1,022 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov