Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Study Overview
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Brief Summary
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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)).

Official Title
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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Conditions
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Out-Of-Hospital Cardiac Arrest, Hypothermia, Ventricular Fibrillation

Intervention / Treatment
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* Device: Early transnasal evaporative cooling with the RhinoChill device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized by EMS personnel at the scene of cardiac arrest to either a) intervention: early transnasal evaporative cooling initiated within 20 minutes from EMS arrival, and subsequent systemic hypothermia at 33°C for 24 h and fever control for 72 h in the ICU, or b) control: standard ACLS (advanced cardiac life support) and fever control (normothermia) for 72 h in the ICU.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early transnasal evaporative cooling with the RhinoChill device<br>Early transnasal evaporative cooling initiated during ACLS at the scene of the cardiac arrest within 20 minutes from EMS arrival and subsequent hypothermia at 33ºC for 24 hours and fever control for 72 hours at the ICU | Device: Early transnasal evaporative cooling with the RhinoChill device<br>* Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours<br>|
| No Intervention: Standard of care<br>Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital |  | Day 1 | 
| Proportion of patients alive at hospital discharge |  | Day 1-90 | 
| 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. | Day 1-90 | 
| Proportion of patients alive at 90 days |  | Day 90 | 
| Proportion of patients with Modified Rankin scale 0-3 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. | Day 90 | 
| Device related adverse event rate within the first 24 hours | Safety | Day 1 | 
| Composite serious adverse event rate within the first 7 days | Safety | Day 1-7 | 
| Proportion of patients with new cardiac arrest prior to hospital admission | Safety | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic hypothermia, transnasal cooling, neurologic outcome, ultrafast hypothermia, prehospital, ECPR