Clinical trial NCT04282525: Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)
Official title: Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: ECMO
cerebral autoregulation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Istituto Giannina Gaslini
name: University of Cambridge
First posted: 2020-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from 0 to 18 years treated by ECMO

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.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years treated by ECMO

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: Feasibility of continuous cerebral autoregulation monitoring
timeFrame: 12 hours before Extra-Corporeal Membrane Oxygenation
measure: Feasibility of continuous cerebral autoregulation monitoring
timeFrame: During Extra-Corporeal Membrane Oxygenation
measure: Feasibility of continuous cerebral autoregulation monitoring
timeFrame: 12 hours after Extra-Corporeal Membrane Oxygenation
Secondary outcomes:
measure: Correlation between cerebral autoregulation metrics and neurological outcome
timeFrame: 12 hours after Extra-Corporeal Membrane Oxygenation
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
state: Loire-Atlantique
Study officials:
References:
citation: Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Impact of Arterial Carbon Dioxide and Oxygen Content on Cerebral Autoregulation Monitoring Among Children Supported by ECMO. Neurocrit Care. 2021 Oct;35(2):480-490. doi: 10.1007/s12028-021-01201-8. Epub 2021 Mar 9.
citation: Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Continuous Monitoring of Cerebral Autoregulation in Children Supported by Extracorporeal Membrane Oxygenation: A Pilot Study. Neurocrit Care. 2021 Jun;34(3):935-945. doi: 10.1007/s12028-020-01111-1. Epub 2020 Oct 8.