Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Study Overview
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Brief Summary
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Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO treatment. The second objective is to analyze the relationship between CA impairment and neurological outcome.

Detailed Description
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Patients : All children treated by ECMO in the PICU of the Universitary hospital of Nantes, France and of IRCCS Giannina Gaslini Institute, Genoa, Italy Measurements: A correlation coefficient between the variations of regional cerebral oxygen saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx), ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is considered as critical. Neurological outcome is assessed by the onset of an acute neurologic event (ANE) during the ECMO run.

Official Title
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Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Conditions
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Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
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* Other: ECMO for hemodynamic or respiratory indication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years treated by ECMO Exclusion Criteria: Lack of parental consent

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 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

| Intervention/Treatment |
| --- |
|Other: ECMO for hemodynamic or respiratory indication|ECMO for hemodynamic or respiratory indication|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of continuous cerebral autoregulation monitoring | Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation | 12 hours before Extra-Corporeal Membrane Oxygenation | 
| Feasibility of continuous cerebral autoregulation monitoring | Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation | During Extra-Corporeal Membrane Oxygenation | 
| Feasibility of continuous cerebral autoregulation monitoring | Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation | 12 hours after Extra-Corporeal Membrane Oxygenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between cerebral autoregulation metrics and neurological outcome | Correlation between the percentage of time spent in critical region of cerebral autoregulation and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not | 12 hours after Extra-Corporeal Membrane Oxygenation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO, cerebral autoregulation