Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04282525

Acronym

ECMOX1

Enrollment

Registered

2020-02-24

Start date

2018-06-01

Completion date

2019-06-01

Last updated

2020-02-24

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

Conditions

Extracorporeal Membrane Oxygenation Complication

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. 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.

Interventions

OTHERECMO for hemodynamic or respiratory indication

ECMO for hemodynamic or respiratory indication

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 18 Years

Healthy volunteers

Inclusion criteria

* Patients 18 years treated by ECMO

Exclusion criteria

* Lack of parental consent

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of continuous cerebral autoregulation monitoring	12 hours before Extra-Corporeal Membrane Oxygenation	Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation

Secondary

Measure	Time frame	Description
Correlation between cerebral autoregulation metrics and neurological outcome	12 hours after Extra-Corporeal Membrane Oxygenation	Correlation between the percentage of time spent in critical region of cerebral autoregulation and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026