Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)

Karolinska Institute

Status: Enrolling

Conditions: Out-Of-Hospital Cardiac Arrest; Ventricular Fibrillation; Hypothermia

Treatments: Device: Early transnasal evaporative cooling with the RhinoChill device

Study type: Interventional

Funder types: Other

Identifiers

NCT06025123

2022-02446-01

Details and patient eligibility

About

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)).

Enrollment: 1,022 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients ≥18 years that meet all of the following inclusion criteria:

1. Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
2. Unconsciousness defined as Glasgow Coma Scale < 8
3. Inclusion within 20 minutes from EMS arrival

Exclusion criteria

Patients are not eligible if they meet one or more of the following criteria:

1. Age ≥ 80 years
2. Obvious non-cardiac causes to cardiac arrest
3. Obvious already hypothermic
4. Obvious barrier to placing intra nasal catheters
5. Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
6. Have a known terminal disease
7. Known or clinically apparent pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,022 participants in 2 patient groups

Early transnasal evaporative cooling with the RhinoChill device

Experimental group

Description:

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

Treatment:

Device: Early transnasal evaporative cooling with the RhinoChill device

Standard of care

No Intervention group

Description:

Standard advanced cardiac life support, subsequent fever control (Normothermia) for 72 hours at ICU