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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Acute Respiratory Distress Syndrome (ARDS); Cardiogenic Shock; Cardiac Arrest

Study type: Observational

Funder types: Other

Identifiers

NCT04548739

RC20_0066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

• Lack of parental consent