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Table 1 Summary of study phases as per the proposed timeline and expected activities during respective time intervals

From: Hyperinvasive approach to out-of hospital cardiac arrest using mechanical chest compression device, prehospital intraarrest cooling, extracorporeal life support and early invasive assessment compared to standard of care. A randomized parallel groups comparative study proposal. “Prague OHCA study”

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
  1. Abbreviations: ACLS: advanced cardiac life support; AG: angiography; ASAP: as soon as possible; BLS: basic life support; CPC: cerebral performance category; CPR: cardiopulmonary resuscitation; CT: computed tomography; ECLS: extracorporeal life support; EMS: emergency medical service; ICU: intensive care unit; I/E: inclusion/exclusion; NIRS: near infrared spectroscopy; OHCA: out of hospital cardiac arrest; ROSC: return of spontaneous circulation; STEMI: ST elevation acute myocardial infarction; TTE: transthoracic echocardiography.