Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

NCT06025123 | Recruiting DMC

• 1 other identifier: 2022-02446-01
• Study Type: interventional
• Target: 1,022
• Locations: 7 countries
• Sites: 11

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)).

Conditions

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

Keywords

Therapeutic hypothermia; transnasal cooling; neurologic outcome; ultrafast hypothermia; prehospital; ECPR

Outcome Measures

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.

  Day 90

Secondary Outcomes (8)

• 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

  Day 1-90

• Proportion of patients alive at 90 days

  Day 90

• Proportion of patients with Modified Rankin scale 0-3 at 90 days

  Day 90

Other Outcomes (6)

• Hospital-free days alive at 90 days

  Day 90

• Distribution of modified Rankin scale at 90 days

  Day 90

• Distribution of Cerebral Performance Category scale at 90 days

  Day 90

Study Arms (2)

Early transnasal evaporative cooling with the RhinoChill device

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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

Interventions

Early transnasal evaporative cooling with the RhinoChill device DEVICE

Early prehospital transnasal evaporative cooling followed by systemic hypothermia to 33 degrees Celsius for 24 hours and fever control for 72 hours

Early transnasal evaporative cooling with the RhinoChill device

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
• Unconsciousness defined as Glasgow Coma Scale \< 8

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (11)

University Hospital Vienna

Vienna, Austria

NOT YET RECRUITING

CHU Saint-Pierre

Brussels, Belgium

RECRUITING

Erasme University Hospital

Brussels, Belgium

RECRUITING

Europe Hospitals St Elizabeth

Brussels, Belgium

RECRUITING

University Hospital Freiburg

Freiburg im Breisgau, Germany

RECRUITING

Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

Ljubljana University Medical Centre

Ljubljana, Slovenia

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

San Carlos Clinical Hospital

Madrid, Spain

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Dillenbeck E, Hollenberg J, Holzer M, Busch HJ, Nichol G, Radsel P, Belohlavec J, Torres EC, Lopez-de-Sa E, Rosell F, Ristagno G, Forsberg S, Annoni F, Svensson L, Jonsson M, Backstrom D, Gellerfors M, Awad A, Taccone FS, Nordberg P. The design of the PRINCESS 2 trial: A randomized trial to study the impact of ultrafast hypothermia on complete neurologic recovery after out-of-hospital cardiac arrest with initial shockable rhythm. Am Heart J. 2024 May;271:97-108. doi: 10.1016/j.ahj.2024.02.020. Epub 2024 Feb 28.

  PMID: 38417773 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Hypothermia; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Pathologic Processes

Study Officials

• Per Nordberg, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Per Nordberg, MD, PhD

CONTACT

+46702802579; per.nordberg@ki.se

Emelie Dillenbeck, MD

CONTACT

+46736484567; emelie.dillenbeck@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients in the intervention group will be treated with hypothermia, which makes blinding for care provider and next of kin difficult in the intervention phase (first 36 h). Participants will be informed of which group the were assigned to if they regained consciousness. The study personnel assessing neurologic outcome at discharge and at 90 days will be blinded for which study group the participant belongs to. In addition, the physician performing the prognostication at 72 hours from cardiac arrest will be a neurologist, intensivist or other specialist experienced and will be blinded for group allocation, but not for relevant clinical data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant in cardiology and intensive care, Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: September 6, 2023
• Study Start: March 27, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1); SE (2); AU (1); ES (2); IT (1); BE (3); DE (1)