Observational Study to Assess Optimal ECPR Settings After Resuscitation

Study Overview
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Brief Summary
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Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain. Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR. Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients. Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.

Official Title
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Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation

Conditions
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Extracorporeal Cardiopulmonary Resuscitation, Cardiac Arrest

Intervention / Treatment
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* Other: Settings of the extracorporeal membrane oxygenation (ECMO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement) Age>18 and < 70 years Duration of low-flow < 60 min before decision to proceed with ECPR High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC) Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG) Cerebral oxymetry monitoring initiated during CPR preceding ECPR Exclusion Criteria: Patients with a GCS<15 before CPR. Known pre-arrest cerebral performance category CPC ≥ 3 Presumed noncardiac cause Unwitnessed collapse Suspected or confirmed pregnancy ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (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 to therapy Do not resuscitate order or other circumstances that make 180 day survival unlikely

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECPR<br>All patients who received ECMO placement during cardiopulmonary resuscitation (ECPR) | Other: Settings of the extracorporeal membrane oxygenation (ECMO)<br>* Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score<br>* Other names: Measurements of cerebral saturation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPC score 6 months | To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* ≤ 2 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPC score discharge | Parameters correlated with a CPC* ≤ 2 | 6 months | 
| Glasgow coma scale (GCS) day 28 | Parameters correlated with a GCS>13 | 6 months | 
| GCS total | Parameters correlated with a GCS > 13 | 6 months | 
| 28 day mortality | Parameters correlated to 28 days mortality | 6 months | 
| Hospital survival | Parameters correlated to hospital survival | 6 months |