Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1) (ECMOX1)

February 21, 2020 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment

Other: ECMO for hemodynamic or respiratory indication

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- Loire-Atlantique
  - Nantes, Loire-Atlantique, France, 44093
    - University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from 0 to 18 years treated by ECMO

Description

Inclusion Criteria:

Patients 18 years treated by ECMO

Exclusion Criteria:

Lack of parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 hours before Extra-Corporeal Membrane Oxygenation
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	During Extra-Corporeal Membrane Oxygenation
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	12 hours after Extra-Corporeal Membrane Oxygenation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 hours after Extra-Corporeal Membrane Oxygenation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

University of Cambridge

Istituto Giannina Gaslini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)