Clinical trial NCT04548739: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Official title: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Cardiogenic Shock
Cardiac Arrest
Keywords: ECMO
Cerebral autoregulation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Istituto Giannina Gaslini
name: Pediatric Intensive Care Unit, Trousseau University Hospital, France
name: Pediatric Intensive Care Unit, Necker University Hospital, France
name: Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK
First posted: 2020-09-14
Enrollment: 132
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: NON_PROBABILITY_SAMPLE
Study population: 100 children admitted to the Pediatric Intensive Care Unit (PICU) of Nantes (France), Trousseau (Paris, France), Necker (Paris, France) or Genoa (Italy) and supported by ECMO for hemodynamic or respiratory indication or during cardiac arrest resuscitation will be included in the study.

As ECMO is an emergency procedure, emergency inclusions may be needed. Other observational study may be conducted in parallel in this population.

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. 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria :

* Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

* Lack of parental consent

Primary outcomes:
measure: Association between CA metrics and neurological outcome
timeFrame: 1 year
Secondary outcomes:
measure: Analysis of the influence of PCO2 on CA
timeFrame: 1 year
measure: Analysis of the influence of PCO2 on CA
timeFrame: 1 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: AP-HP Trousseau Hospital
city: Paris
country: France
facility: AP-HP Necker Hospital
city: Genova
country: Italy
facility: Giannina Gaslini Institute (IRCCS)
Study officials:
affiliation: Nantes University Hospital
name: Nicolas JORAM, MD
role: PRINCIPAL_INVESTIGATOR
References: