Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication

• Registration Number: NCT04282525
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients 18 years treated by ECMO

Exclusion Criteria

• Lack of parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of continuous cerebral autoregulation monitoring	12 hours after Extra-Corporeal Membrane Oxygenation	Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France