Hôpital Trousseau
Paris, 75012, France
Location status: Recruiting
Location contact
Garance Martin, MD
CONTACT
Pierre-Louis Léger, MD, PhD
SUB_INVESTIGATOR
Yaël Levy, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05237232
Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Recruiting
Interested in participating?
Request InfoKey information
Age range
Up to 17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
When ECMO is stopped, carotid decanulation is done either by ligation or by reconstruction, depending on the practices of the surgical team and the peroperative findings. The reconstruction allows a restoration of blood flow to the internal carotid artery and the middle cerebral artery with a disappearance of compensation by the circle of Willis.
Vascular flow modeling is a computational method derived from imaging for the hemodynamic study of fluids, including pressures and flow rates at different points in a vessel. Data from the literature on the modeling of cerebral vascularization in newborns are scarce.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For everyone :
- Information and non-opposition of holders of parental authority
- Newborn, infant and child <20kg
- Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
- Performing a Magnetic Resonance Angiography (MRA) as part of the treatment
For patients treated with ECMO: study population
- Hemodynamic or respiratory failure
- Requiring the use of extracorporeal circulation with jugulo-carotid cannulation
- Weaned alive off Extra corporeal membrane oxygenation (ECMO)
For patients with hypoxic-ischemic encephalopathy: control population
- hypoxic-ischemic encephalopathy diagnosed at birth
Exclusion criteria
- Contraindication to MRA
- Opposition of holders of parental authority
Treatment and study plan
Magnetic Resonance Angiography (MRA) additional acquisition time
OtherAdditional acquisition time, time of flight, during brain MRA of the care allowing to obtain the same quality of vascular anatomical visualization as the brain MRA with gadolinium contrast medium injection performed for the care of the patients treated with jugulocarotid ECMO.
Modeling cerebral vascularization
OtherThe modeling of cerebral vascularization from CRIMSON software (CaRdiovascular Integrated Modeling & Simulation) requires several inputs:
- The MRA images
- The cardiac function curve
- The cerebral blood flow
- Measurement of systolic, diastolic and mean arterial blood pressure
Primary outcomes
-
Intracerebral arterial flows of patients treated with ECMO
Time frame: 1 month
Comparison of intracerebral arterial flows according to the technique of reconstruction of the common carotid artery (reconstruction or ligation) after decanulation from data of MRA performed in weaned living patients off ECMO using computational fluid dynamic.
Secondary outcomes
-
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO
Time frame: 1 month
Brain Magnetic Resonance Angiography (MRA)
-
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy
Time frame: 1 month
Additional acquisition time, time of flight, during brain Magnetic Resonance Angiography. (MRA) of the care.
Modeling of the normal cerebral vascularization in children and infants / newborns.
-
Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy
Time frame: 1 month
Comparison of intracerebral arterial flows between patients treated with ECMO and those treated for anoxo-ischemia from data of MRA and by using computational fluid dynamic.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Collaborators
- URC-CIC Paris Descartes Necker Cochin
Registry information
Official study title
Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows
Acronym: MoVa-ECMO
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 14, 2022
- Registry last updated
- Sep 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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