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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
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
Treatment groups
1,022 Participants
are divided into 2 treatment groupsGroup A: Early transnasal evaporative cooling with the RhinoChill deviceExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.
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.
Time frame
Day 90Secondary outcomes
1
Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital
Time frame
Day 12
Proportion of patients alive at hospital discharge
Time frame
Day 1-903
Proportion of patients with Modified Rankin scale 0-3 at hospital discharge
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.
Time frame
Day 1-904
Proportion of patients alive at 90 days
Time frame
Day 90Other outcomes
1
Hospital-free days alive at 90 days
Time frame
Day 902
Distribution of modified Rankin scale at 90 days
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.
Time frame
Day 903
Distribution of Cerebral Performance Category scale at 90 days
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.
Time frame
Day 904
Proportion of patients alive after 1 year
Time frame
Day 365Sponsors and contacts
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Source ClinicalTrials.gov