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Search / Trial NCT06025123

Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

Launched by KAROLINSKA INSTITUTET · Sep 1, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Therapeutic Hypothermia Transnasal Cooling Neurologic Outcome Ultrafast Hypothermia Prehospital Ecpr

ClinConnect Summary

The Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2 is a clinical trial that aims to find out if a special cooling method used immediately after a cardiac arrest can help improve survival and brain recovery compared to standard treatment. This study focuses on adults aged 18 to 79 who experience a cardiac arrest outside of the hospital, particularly those whose hearts can be shocked back into a normal rhythm. The main question is whether people who receive this cooling treatment right away will have better outcomes 90 days later compared to those who receive standard care, which keeps their body temperature normal.

Eligible participants will be those who are unconscious and have had a cardiac arrest with a shockable heart rhythm, and they must be included in the study within 20 minutes of emergency medical services arriving. Participants will be randomly assigned to one of two groups: one will receive the cooling treatment right at the scene, followed by continued cooling in the hospital, while the other will get the usual emergency care and maintain a normal body temperature. This trial is currently recruiting and aims to provide important information on improving care for cardiac arrest patients.

Gender

ALL

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

About Karolinska Institutet

Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.

Locations

Madrid, , Spain

Vienna, , Austria

Madrid, , Spain

Stockholm, , Sweden

Brussels, , Belgium

Stockholm, , Sweden

Stockholm, , Sweden

Freiburg, , Germany

Ljubljana, , Slovenia

Prague, , Czechia

Milano, , Italy

Patients applied

0 patients applied

Trial Officials

Per Nordberg, MD, PhD

Principal Investigator

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported