Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extracorporeal Cardiopulmonary Resuscitation
- Sponsor
- Erasmus Medical Center
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- CPC score 6 months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Loes Mandigers, MD
Principal Investigator
Erasmus Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
CPC score 6 months
Time Frame: 6 months
To prospectively identify parameters correlated with Cerebral Performance Category (CPC)\* ≤ 2
Secondary Outcomes
- Glasgow coma scale (GCS) day 28(6 months)
- 28 day mortality(6 months)
- CPC score discharge(6 months)
- GCS total(6 months)
- Hospital survival(6 months)