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

January 10, 2024 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

132

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
      • Nantes, France
        • CHU de Nantes
      • Paris, France, 75012
        • AP-HP Trousseau Hospital
      • Paris, France, 75015
        • AP-HP Necker Hospital
  • Italy
      • Genova, Italy, 16148
        • Giannina Gaslini Institute (IRCCS)

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

No

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.

Description

Inclusion Criteria :

  • Patients under the age of 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the influence of PCO2 on CA
Time Frame: 1 year
Association between PCO2 value (mmHg) and COX value
1 year
Analysis of the influence of PCO2 on CA
Time Frame: 1 year
Influence of ECMO settings on CA
1 year

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Nicolas JORAM, MD, Nantes University Hospital

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)

October 22, 2020

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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