Hypothermia, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation
Conditions
Keywords
Therapeutic hypothermia, transnasal cooling, neurologic outcome, ultrafast hypothermia, prehospital, ECPR
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)).
Interventions
DEVICEEarly 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
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 alive at 90 days | Day 90 | — |
| 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 |
| Composite serious adverse event rate within the first 7 days | Day 1-7 | Safety |
| Proportion of patients with new cardiac arrest prior to hospital admission | Day 1 | Safety |
Countries
Austria, Belgium, Germany, Italy, Norway, Slovenia, Spain, Sweden
Contacts
CONTACTPer Nordberg, MD, PhD
CONTACTEmelie Dillenbeck, MD
PRINCIPAL_INVESTIGATORPer Nordberg, MD, PhD
Karolinska Institutet
Outcome results
None listed