Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

Last updated: January 10, 2024
Sponsor: Nantes University Hospital
Overall Status: Completed

Phase

N/A

Condition

Acute Respiratory Distress Syndrome (Ards)

Circulation Disorders

Lung Injury

Treatment

N/A

Clinical Study ID

NCT04548739
RC20_0066
  • Ages 1-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria :

  • Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

  • Lack of parental consent

Study Design

Total Participants: 132
Study Start date:
October 22, 2020
Estimated Completion Date:
October 16, 2023

Study 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.

Connect with a study center

  • CHU de Nantes

    Nantes,
    France

    Site Not Available

  • AP-HP Necker Hospital

    Paris, 75015
    France

    Site Not Available

  • AP-HP Trousseau Hospital

    Paris, 75012
    France

    Site Not Available

  • Giannina Gaslini Institute (IRCCS)

    Genova, 16148
    Italy

    Site Not Available

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