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Clinical Trials/NCT04282525
NCT04282525
Completed
Not Applicable

Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Nantes University Hospital1 site in 1 country30 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extracorporeal Membrane Oxygenation Complication
Sponsor
Nantes University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of continuous cerebral autoregulation monitoring
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
June 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients 18 years treated by ECMO

Exclusion Criteria

  • Lack of parental consent

Outcomes

Primary Outcomes

Feasibility of continuous cerebral autoregulation monitoring

Time Frame: 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 Outcomes

  • Correlation between cerebral autoregulation metrics and neurological outcome(12 hours after Extra-Corporeal Membrane Oxygenation)

Study Sites (1)

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