Clinical trial NCT06025123: Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
Official title: Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 (PRINCESS2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Hypothermia
Ventricular Fibrillation
Keywords: Therapeutic hypothermia
transnasal cooling
neurologic outcome
ultrafast hypothermia
prehospital
ECPR
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 1022
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1.
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital
timeFrame: Day 1
measure: Proportion of patients alive at hospital discharge
timeFrame: Day 1-90
measure: Proportion of patients with Modified Rankin scale 0-3 at hospital discharge
timeFrame: Day 1-90
measure: Proportion of patients alive at 90 days
timeFrame: Day 90
measure: Proportion of patients with Modified Rankin scale 0-3 at 90 days
timeFrame: Day 90
measure: Device related adverse event rate within the first 24 hours
timeFrame: Day 1
measure: Composite serious adverse event rate within the first 7 days
timeFrame: Day 1-7
measure: Proportion of patients with new cardiac arrest prior to hospital admission
timeFrame: Day 1
Other outcomes:
measure: Hospital-free days alive at 90 days
timeFrame: Day 90
measure: Distribution of modified Rankin scale at 90 days
timeFrame: Day 90
measure: Distribution of Cerebral Performance Category scale at 90 days
timeFrame: Day 90
measure: Proportion of patients alive after 1 year
timeFrame: Day 365
measure: Proportion of patients with Modified Rankin scale 0-1 at 1 year
timeFrame: Day 365
measure: Quality of life assessed with EQ-5D-5L at 90 days
timeFrame: Day 90
Locations:
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Brussels
country: Belgium
facility: Erasme University Hospital
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Milano
country: Italy
facility: Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Ljubljana
country: Slovenia
facility: Ljubljana University Medical Centre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Per Nordberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: