NCT04282525

Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (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. 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

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.

Conditions

• Extracorporeal Membrane Oxygenation Complication

Interventions

Type	Name	Description
OTHER	ECMO for hemodynamic or respiratory indication	ECMO for hemodynamic or respiratory indication

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2020-02-24
• Last updated: 2020-02-24

Locations

1 site across 1 country: France