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Recruiting NCT05237232

Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

— Observational Extra Corporeal Membrane Oxygenation Decanulated Alive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Angiography (MRA) additional acquisition time, Modeling cerebral vascularization.
Who it may be relevant to
Registry conditions: Extra Corporeal Membrane Oxygenation, Decanulated Alive. Basic parameters: up to 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • Other Magnetic 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.
  • Other Modeling 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

Primary outcome measures

  • Intracerebral arterial flows of patients treated with ECMO [Time frame: 1 month]
Secondary outcome measures (3)
  • Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO [Time frame: 1 month]
  • Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy [Time frame: 1 month]
  • Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Hôpital Trousseau — Paris

Identifiers

NCT: NCT05237232 · APHP211306 · 2021-A01935-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗