Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)

NCT ID: NCT04282525

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Extracorporeal Membrane Oxygenation Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ECMO for hemodynamic or respiratory indication

ECMO for hemodynamic or respiratory indication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years treated by ECMO

Exclusion Criteria

* Lack of parental consent
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Giannina Gaslini

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Nantes, Loire-Atlantique, France

Site Status

Countries

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France

References

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Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Impact of Arterial Carbon Dioxide and Oxygen Content on Cerebral Autoregulation Monitoring Among Children Supported by ECMO. Neurocrit Care. 2021 Oct;35(2):480-490. doi: 10.1007/s12028-021-01201-8. Epub 2021 Mar 9.

Reference Type DERIVED
PMID: 33686559 (View on PubMed)

Joram N, Beqiri E, Pezzato S, Moscatelli A, Robba C, Liet JM, Chenouard A, Bourgoin P, Czosnyka M, Leger PL, Smielewski P. Continuous Monitoring of Cerebral Autoregulation in Children Supported by Extracorporeal Membrane Oxygenation: A Pilot Study. Neurocrit Care. 2021 Jun;34(3):935-945. doi: 10.1007/s12028-020-01111-1. Epub 2020 Oct 8.

Reference Type DERIVED
PMID: 33029743 (View on PubMed)

Other Identifiers

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ECMOX1

Identifier Type: -

Identifier Source: org_study_id

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