Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— ECMOX1  

Official title:

Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282525
• Other study ID #: ECMOX1
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patients 18 years treated by ECMO

Exclusion Criteria:

• Lack of parental consent

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Other:
• ECMO for hemodynamic or respiratory indication
ECMO for hemodynamic or respiratory indication

Locations

Country	Name	City	State
France	University Hospital	Nantes	Loire-Atlantique

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Istituto Giannina Gaslini, University of Cambridge

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of continuous cerebral autoregulation monitoring	Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation	12 hours before Extra-Corporeal Membrane Oxygenation
Primary	Feasibility of continuous cerebral autoregulation monitoring	Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation	During Extra-Corporeal Membrane Oxygenation
Primary	Feasibility of continuous cerebral autoregulation monitoring	Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation	12 hours after Extra-Corporeal Membrane Oxygenation
Secondary	Correlation between cerebral autoregulation metrics and neurological outcome	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	12 hours after Extra-Corporeal Membrane Oxygenation