Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

NCT04282525 — Completed, 30 participants, Nantes University Hospital

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RegistryNCT04282525, acronym ECMOX1
StatusCompleted
Study typeObservational
Enrollment30 (Actual)
SponsorNantes University Hospital (Other); collaborators: Istituto Giannina Gaslini, University of Cambridge
ConditionsExtracorporeal Membrane Oxygenation Complication
InterventionsECMO for hemodynamic or respiratory indication (Other)
Datesstart 2018-06-01, primary completion 2019-06-01, completion 2019-06-01, first posted 2020-02-24, last updated 2020-02-24
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Extracorporeal Membrane Oxygenation Complication All trials of ECMO for hemodynamic or respiratory indication

-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.

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • 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
  • Feasibility of continuous cerebral autoregulation monitoring [During Extra-Corporeal Membrane Oxygenation]: Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation
  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 1 Day to 18 Years

Inclusion Criteria:

* Patients 18 years treated by ECMO

Exclusion Criteria:

* Lack of parental consent

+Locations (1)

FacilityCityCountryStatus
University HospitalNantes, Loire-AtlantiqueFrance

+Publications

  • Results publication: 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. PMID 33686559
  • Results publication: 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. PMID 33029743