Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children (MoVa-ECMO)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Extra Corporeal Membrane Oxygenation; Decanulated Alive
• Intervention / Treatment: Other: Modeling cerebral vascularization; Other: Magnetic Resonance Angiography (MRA) additional acquisition time

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).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Sabine Irtan, MD, PhD; Phone Number: +33 1 71 73 87 98; Email: sabine.irtan@aphp.fr
• Study Contact Backup: Name: Hélène Morel; Phone Number: +33 1 71 19 63 46; Email: helene.morel@aphp.fr

Study Locations

• France
  • Paris, France, 75012
    • Recruiting
    • Hôpital Trousseau
    • Contact: Garance Martin, MD; Email: garance.martin@aphp.fr
    • Sub-Investigator: Pierre-Louis Léger, MD, PhD
    • Principal Investigator: Yaël Levy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Newborns, infants and children having been treated with jugulocarotid ECMO and weaned alive off ECMO and newborns treated for hypoxic-ischemic encephalopathy, hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Newborns, infants and children hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital, having been treated with jugulocarotid ECMO and weaned alive off 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
Controls; Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital.	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracerebral arterial flows of patients treated with ECMO	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy	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.	1 month
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO	Brain Magnetic Resonance Angiography (MRA)	1 month
Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy	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.	1 month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC Necker Cochin, France
• Investigators: Principal Investigator: Sabine Irtan, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Garance Martin, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Magnetic Resonance Angiography; Pediatric patients; Extra corporeal membrane oxygenation; Arterial circulation; Techniques of carotid decanulation; Circle of Willis
• Additional Relevant MeSH Terms: tocilizumab
• Other Study ID Numbers: APHP211306; 2021-A01935-36 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No