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Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05237232
Acronym
MoVa-ECMO
Enrollment
30
Registered
2022-02-14
Start date
2022-03-31
Completion date
2026-08-31
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decanulated Alive, Extra Corporeal Membrane Oxygenation

Keywords

Extra corporeal membrane oxygenation, Pediatric patients, Arterial circulation, Techniques of carotid decanulation, Circle of Willis, Magnetic Resonance Angiography

Brief summary

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).

Detailed description

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).

Interventions

OTHERMagnetic Resonance Angiography (MRA) additional acquisition time

Additional 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.

OTHERModeling cerebral vascularization

The 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

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

For everyone : 1. Information and non-opposition of holders of parental authority 2. Newborn, infant and child \<20kg 3. Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital 4. Performing a Magnetic Resonance Angiography (MRA) as part of the treatment For patients treated with ECMO: study population 5. Hemodynamic or respiratory failure 6. Requiring the use of extracorporeal circulation with jugulo-carotid cannulation 7. Weaned alive off Extra corporeal membrane oxygenation (ECMO) For patients with hypoxic-ischemic encephalopathy: control population 8. hypoxic-ischemic encephalopathy diagnosed at birth

Exclusion criteria

1. Contraindication to MRA 2. Opposition of holders of parental authority

Design outcomes

Primary

MeasureTime frameDescription
Intracerebral arterial flows of patients treated with ECMO1 monthComparison 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

MeasureTime frameDescription
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO1 monthBrain Magnetic Resonance Angiography (MRA)
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy1 monthAdditional 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 encephalopathy1 monthComparison 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.

Countries

France

Contacts

Primary ContactSabine Irtan, MD, PhD
sabine.irtan@aphp.fr1 71 73 87 98
Backup ContactHélène Morel
helene.morel@aphp.fr1 71 19 63 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026