Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2
- Conditions
- Ventricular FibrillationHypothermiaOut-Of-Hospital Cardiac Arrest
- Interventions
- Device: Early transnasal evaporative cooling with the RhinoChill device
- Registration Number
- NCT06025123
- Lead Sponsor
- Karolinska Institutet
- 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)).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1022
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early transnasal evaporative cooling with the RhinoChill device Early transnasal evaporative cooling with the RhinoChill device 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
- Primary Outcome Measures
Name Time Method Proportion of patients surviving with complete neurologic recovery at 90 days defined as modified Rankin scale (mRs) of 0-1. Day 90 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.
- Secondary Outcome Measures
Name Time Method Proportion of patients alive at hospital discharge Day 1-90 Proportion of patients with sustained ROSC (return of spontaneous circulation) and admitted alive to hospital Day 1 Proportion of patients alive at 90 days Day 90 Proportion of patients with Modified Rankin scale 0-3 at hospital discharge Day 1-90 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.
Proportion of patients with Modified Rankin scale 0-3 at 90 days Day 90 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.
Device related adverse event rate within the first 24 hours Day 1 Safety
Proportion of patients with new cardiac arrest prior to hospital admission Day 1 Safety
Composite serious adverse event rate within the first 7 days Day 1-7 Safety
Trial Locations
- Locations (8)
University Hospital Vienna
🇦🇹Vienna, Austria
Erasme University Hospital
🇧🇪Brussels, Belgium
University Hospital Freiburg
🇩🇪Freiburg, Germany
Department of Anesthesiology, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Ljubljana University Medical Centre
🇸🇮Ljubljana, Slovenia
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden