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Completed

NCT Number: NCT04282525

Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

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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Key information

Conditions

Extracorporeal Membrane Oxygenation Complication

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years treated by ECMO

Exclusion criteria

  • Lack of parental consent

Treatment and study plan

ECMO for hemodynamic or respiratory indication

Other

ECMO for hemodynamic or respiratory indication

Primary outcomes

  1. Feasibility of continuous cerebral autoregulation monitoring

    Time frame: 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

  2. Feasibility of continuous cerebral autoregulation monitoring

    Time frame: During Extra-Corporeal Membrane Oxygenation

    Percentage of time when cerebral autoregulation metrics are available. cerebral autoregulation metrics variations under Extra-Corporeal Membrane Oxygenation

  3. 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

  1. Correlation between cerebral autoregulation metrics and neurological outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Istituto Giannina Gaslini
  • University of Cambridge

Registry information

Acronym: ECMOX1

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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