NCT04548739

Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)
• Cardiogenic Shock
• Cardiac Arrest

Timeline

• Start date: 2020-10-22
• Primary completion: 2023-10-16
• Completion: 2023-10-16
• First posted: 2020-09-14
• Last updated: 2024-01-11

Locations

4 sites across 2 countries: France, Italy