Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04548739

Acronym

ECMO-ECMOX2

Enrollment

132

Registered

2020-09-14

Start date

2020-10-22

Completion date

2023-10-16

Last updated

2024-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ECMO, Cerebral autoregulation

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

Inclusion criteria

: * Patients under the age of 18 years treated by ECMO

Exclusion criteria

: * Lack of parental consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Analysis of the influence of PCO2 on CA	1 year	Association between PCO2 value (mmHg) and COX value

Countries

France, Italy

Outcome results