Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
- Conditions
- Acute Respiratory Distress Syndrome (ARDS)Cardiac ArrestCardiogenic Shock
- Registration Number
- NCT04548739
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.
- Detailed Description
Patients : All children treated by ECMO in the 4 PICUs involved in the study
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Association between CA metrics and neurological outcome 1 year Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not.
- Secondary Outcome Measures
Name Time Method Analysis of the influence of PCO2 on CA 1 year Influence of ECMO settings on CA
Trial Locations
- Locations (4)
AP-HP Necker Hospital
🇫🇷Paris, France
AP-HP Trousseau Hospital
🇫🇷Paris, France
CHU de Nantes
🇫🇷Nantes, France
Giannina Gaslini Institute (IRCCS)
🇮🇹Genova, Italy