Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

NCT ID: NCT05237232

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2026-08-31

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).

Conditions

Extra Corporeal Membrane Oxygenation; Decanulated Alive

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Modeling cerebral vascularization

Intervention Type: OTHER

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.

Magnetic Resonance Angiography (MRA) additional acquisition time

Intervention Type: OTHER

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.

Modeling cerebral vascularization

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine Irtan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Garance Martin, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Trousseau

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sabine Irtan, MD, PhD

Role: CONTACT

sabine.irtan@aphp.fr

1 71 73 87 98 ext. +33

Hélène Morel

Role: CONTACT

helene.morel@aphp.fr

1 71 19 63 46 ext. +33

Facility Contacts

Garance Martin, MD

Role: primary

garance.martin@aphp.fr

Other Identifiers

2021-A01935-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211306

Identifier Type: -

Identifier Source: org_study_id