- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04282525
Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1) (ECMOX1)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44093
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients 18 years treated by ECMO
Exclusion Criteria:
- Lack of parental consent
Study Plan
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
Sponsor
Publications and helpful links
General Publications
- Joram N, Beqiri E, Pezzato S, Andrea M, 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.
- Joram N, Beqiri E, Pezzato S, Andrea M, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ECMOX1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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