Skip to main content
OpenTrials
Completed

NCT Number: NCT04548739

Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

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. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Cardiac Arrest Cardiogenic Shock Cardiovascular Diseases Heart Arrest Heart Diseases Infarction Ischemia Lung Diseases Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Shock Shock, Cardiogenic Vascular Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes, Nantes, France

Loading trial locations.

About this study

Patients : All children treated by ECMO in the 4 PICUs involved in the study

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 under the age of 18 years treated by ECMO

Exclusion criteria

  • Lack of parental consent

Treatment and study plan

Primary outcomes

  1. Association between CA metrics and neurological outcome

    Time frame: 1 year

    Association between the percentage of time spent in critical region of CA and the onset of an acute neurological event (stroke and/or seizures and/or brain death) or not.

Secondary outcomes

  1. Analysis of the influence of PCO2 on CA

    Time frame: 1 year

    Association between PCO2 value (mmHg) and COX value

  2. Analysis of the influence of PCO2 on CA

    Time frame: 1 year

    Influence of ECMO settings on CA

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
  • Istituto Giannina Gaslini
  • Pediatric Intensive Care Unit, Necker University Hospital, France
  • Pediatric Intensive Care Unit, Trousseau University Hospital, France

Registry information

Official study title

Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2

Acronym: ECMO-ECMOX2

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2020
Registry last updated
Jan 11, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.