Cardiac Arrest Extra Corporeal Oxygenation Membrane

Study Overview
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Brief Summary
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French guidelines for Cardio Pulmonary Resuscitation (CPR) consider Extra-Corporeal Life Support (ECLS) as one option in Refractory out-of hospital Cardiac Arrest (ROHCA) patients with a no-flow less than five minutes and absence of spontaneous circulation 30 minutes after initiation of advanced CPR. Duration of both pre-CPR arrest (no-flow) and of CPR (low-flow) have been systematically highlighted as crucial prognostic factors in all observational studies focused on ROHCA. In order to shorten the time to ECLS initiation, the most recent European Resuscitation Council guidelines recommend, in eligible ROHCA patients, a fast track access to ECLS implantation. CHRU Nancy elaborated an operational strategy which was designed to improve the enrolment of eligible ROHCA patients and to reduce the delay time between recognition and ECLS initiation. The objective of the present register was to assess prospectively the impact of this new operational strategy over a 5 years period.

Official Title
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Refractory Cardiac Arrest Management With Veno-Arterial Extra Corporeal Oxygenation Membrane Registry

Conditions
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Cardiac Arrest, Cardiopulmonary Resuscitation, Advanced Cardiac Life Support, Extracorporeal Life Support

Intervention / Treatment
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* Procedure: Fast track access to vaECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed out-of-hospital cardiac arrest in qualified geographical locations No Return of spontaneous circulation (ROSC) after 10 min of CPR No Flow <1 min Exclusion Criteria: Apparent obvious comorbidities Patient < 18 yo Pregnancy Patient under protective supervision

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, monocentric, open, routine care assessment study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ROHCA rescued by vaECMO<br>Patients experiencing a ROHCA despite advanced CPR and finally rescued with a va ECMO device. | Procedure: Fast track access to vaECMO<br>* ROHCA must be witnessed with onset of bystander CPR and an immediate call to Emergency Dispatch. Furthermore, to minimize any loss of time, all qualified geographical locations are directly incorporated in the regulation software of the center for medical emergency control. Patients suitable for vaECMO implantation were identified as early as possible by the Medical Dispatcher at the Emergency Call Dispatch Center. Bystanders pursued CPR until Mobile Intensive Care Unit (MICU) arrival. OHCA was considered refractory after 10 min of CPR initiating the transport by MICU to the hospital such that the vaECMO intervention could be performed. The resuscitation was pursued during the transfer to hospital. An automated chest compression device was used in order to minimize interruption periods. The intensivists and cardiac surgeons stood ready to implant the vaECMO surgically in the catheterization laboratory where a percutaneous coronary intervention was subsequently performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survivors without neurological sequelae Number of survivors without neurological sequelae (DRS scale from 0 to 6) | Number of survivors without neurological sequelae (DRS scale from 0 to 6) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of survivors with or without neurological sequelae. | Number of survivors with or without neurological sequelae (DRS from 0 to 29) | at 3 months | 
| Number of survivors with or without neurological sequelae. | European quality of life scale EQ-5D at 3 months | at 3 months | 
| Ischemia-reperfusion assessment | Amount of fluid infused | from ECMO implantation and day 3 | 
| Renal failure | Worst KDIGO stage | ECMO implantation - Day 1- Day 3 | 
| Hepatic failure | Worst values of PT/bilirubin/ AST and ALT | ECMO implantation - Day 1 - Day 3 | 
| Coagulation Failure | platelets/PT/Fibrinogen | ECMO implantation- Day 1 - Day 3 | 
| Respiratory failure | PaO2/iFO2 value | ECMO implantation - Day 1- Day 3 | 
| Hemodynamic Failure | Amount of Norepinephrine infused | from ECMO implantation and day 3 | 
| Quality of Resuscitation | Total duration of the resuscitation: from collapse to ECMO implantation | from collapse to ECMO implantation (up to 60 minutes) | 
| Pupillary status | Pupillary status | at arrival in intensive care - Hour 0 - Hour 6 - Hour 12 - Day 1 | 
| Lactate | amount of Lactate | Hour 0 - Hour 6 - Hour 12 - Day 1 | 
| bispectral index | bispectral index | at arrival in intensive care - Hour 6 - Hour 12 - Day 1 | 
| Nosocomial complications | Infection of the canulation site | ECMO implantation - Day 1 - Day 3 | 
| Nosocomial complications | bacteraemia | ECMO implantation - Day 1 - Day 3 | 
| Bleeding complications | blood hemostasis disorder | ECMO implantation - Day 1 - Day 3 | 
| Bleeding complications | bleeding | ECMO implantation - Day 1 - Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory out-hospital cardiac arrest, Extracorporeal Life Support