Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)

Cardiac Arrest Clinical Trial

— ECMO-ECMOX2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548739
• Other study ID #: RC20_0066
• Status: Completed
• Start date: October 22, 2020
• Est. completion date: October 16, 2023

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria :

• Patients under the age of 18 years treated by ECMO

Exclusion Criteria :

• Lack of parental consent

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Cardiac Arrest
• Cardiogenic Shock
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Shock, Cardiogenic

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
France	AP-HP Necker Hospital	Paris
France	AP-HP Trousseau Hospital	Paris
Italy	Giannina Gaslini Institute (IRCCS)	Genova

Sponsors (5)

Lead Sponsor	Collaborator
Nantes University Hospital	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

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between CA metrics and neurological outcome	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.	1 year
Secondary	Analysis of the influence of PCO2 on CA	Association between PCO2 value (mmHg) and COX value	1 year
Secondary	Analysis of the influence of PCO2 on CA	Influence of ECMO settings on CA	1 year