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

Sponsor

Nantes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04548739

Collaborator

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

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome (ARDS) Cardiogenic Shock Cardiac Arrest

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 22, 2020

Anticipated Primary Completion Date :

Oct 22, 2022

Anticipated Study Completion Date :

Oct 22, 2022

Outcome Measures

Primary Outcome Measures

Association between CA metrics and neurological outcome [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 Outcome Measures

Analysis of the influence of PCO2 on CA [1 year]
Association between PCO2 value (mmHg) and COX value
Analysis of the influence of PCO2 on CA [1 year]
Influence of ECMO settings on CA

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria :

Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

Lack of parental consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU de Nantes	Nantes	France
2	AP-HP Trousseau Hospital	Paris	France	75012
3	AP-HP Necker Hospital	Paris	France	75015
4	Giannina Gaslini Institute (IRCCS)	Genova	Italy	16148

Sponsors and Collaborators

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