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Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

NCT06025123 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1022

Last updated 2025-09-25

No results posted yet for this study

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

Interventions

DEVICE

Early transnasal evaporative cooling with the RhinoChill device

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

Sponsors & Collaborators

Principal Investigators

  • Per Nordberg, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2028-02-29
Completion
2028-05-31

Countries

  • Austria
  • Belgium
  • Germany
  • Italy
  • Slovenia
  • Spain
  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06025123 on ClinicalTrials.gov