Out-of Hospital Cardiac Arrest | Hyperinvasive Approach in Cardiac Arrest
Out-of Hospital Cardiac Arrest research study
What is the primary objective of this study?
Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated \"hyperinvasive\" approach might improve outcome of out-of hospital cardiac arrest victims.
Who is eligible to participate?
Inclusion Criteria: - minimum of 18 and maximum of 65 years - witnessed out-of-hospital cardiac arrest of presumed cardiac cause - minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC - unconsciousness (Glasgow Coma Score < 8) - ECMO team and bed-capacity in cardiac center available. Exclusion Criteria: - OHCA of presumed non-cardiac cause - unwitnessed collapse - pregnancy - sustained ROSC within 5 minutes of ACLS performed by EMS team - conscious patient - known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding - suspected or confirmed acute stroke - known severe chronic organ dysfunction or other limitations in therapy - \"do not resuscitate\" order or other circumstances making 180 day survival unlikely - known pre-arrest cerebral performance category CPC ≥ 3.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Out-of Hospital Cardiac Arrest
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Prehospital mechanical compressions, intraarrest cooling and in hospital ECLSECLS states for extracorporeal life support.
Other:Standard careStandard care as per recent guidelines will be provided.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Hyperinvasive armHyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.
Standard armPatients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.
Start Date: March 2013
Completed Date: May 2018
Phase: Phase 4
Primary Outcome: Composite endpoint of survival with good neurological outcome (CPC 1-2).
Secondary Outcome: Neurological recovery
Study sponsors, principal investigator, and references
Principal Investigator: Jan Belohlavek
Lead Sponsor: Charles University, Czech Republic