Table 1 Summary of study phases as per the proposed timeline and expected activities during respective time intervals
Study phases | Activities to be performed | |
|---|---|---|
Prerandomization | ||
Phase 1 (Time 0 to Time 1) | EMS is activated | |
Aimed to be < 10 min | RRV and ambulance car are dispatched | |
Time 0 = collapse time | Telephone assisted lay person BLS is started | |
Time 1 = EMS team on site | Cardiac center is alerted | |
OHCA confirmed | ||
Phase 2 (Time 1 to Time 2) | ACLS is started by the first crew on site | |
Time 2 = randomization | All initial procedures are performed (defibrillation/s, airway management, i.v. access establishment, etc.) | |
After a minimum of 5 minutes of ACLS guided by EMS physician eligibility for the study is considered (Decision point 1) | ||
Randomization is performed by phone call with cardiac center coordinator | ||
Postrandomization | Standard arm | Hyperinvasive arm |
Phase 3 (Time 2 to Time 3) | Continue ACLS according to recent ERC guidelines, start NIRS monitoring, no mechanical compression device used, no intraarrest cooling | Start mechanical compression device, take tympanic temperature, start NIRS monitoring, start intraarrest cooling |
Prehospital randomized phase | ||
Time 3 = hospital admission | ROSC assessment | Immediate transport to cardiac center cathlab under ongoing CPR, continue ACLS according to recent ERC guidelines |
If ROSC, transport to cardiac center ICU | ||
Prehospital cooling in case of stable ROSC is allowed | If ROSC during transport, continue transport to cathlab, continue cooling and proceed with invasive assessment | |
If death on scene, autopsy at Inst. for Forensic Medicine | If death on scene or during transport, autopsy at Inst. for Forensic Medicine | |
Phase 4 (Time 3 to Time 4) | Standard post cardiac arrest care, mild hypothermia to 33-34°C ASAP | ROSC and shock assessment, urgent brief TTE |
Time 4 = ECLS start – applies for hyperinvasive arm, in standard arm Time 4 = initial assessment | Initial assessment - if STEMI/high risk nonSTEMI proceed to cathlab | ECLS I/E assessment |
Continue NIRS | If no ROSC, or ROSC + shock and no ECLS I/E contraindications – immediate ECLS implantation | |
If death, autopsy at Inst. for Forensic Medicine | Immediate invasive assessment (coronary AG, if normal – pulmonary AG, if normal - aortography, eventually brain CT) | |
Continue NIRS | ||
Continue mild hypothermia to 33-34 C | ||
If death, autopsy at Inst. for Forensic Medicine | ||
Phase 5 (Time 4 to Time 5) | Standard post cardiac arrest care | Continue ECLS until weaning and discontinuation |
Time 5 = 6 months evaluation or time of death | Evaluation of cardiac and neurological recovery within 30 days/until discharge | Assess ECLS related adverse events (bleeding, need for blood products) |
6 months survival with CPC 1–2 assessment | Standard post cardiac arrest care | |
If death, autopsy at Inst. for Forensic Medicine | Evaluation of cardiac and neurological recovery within 30 days/until discharge | |
6 months survival with CPC 1–2 assessment | ||
If death, autopsy at Inst. for Forensic Medicine | ||