Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

Recruiting

• Conditions: Decanulated Alive; Extra Corporeal Membrane Oxygenation
• Interventions: Other: Modeling cerebral vascularization; Other: Magnetic Resonance Angiography (MRA) additional acquisition time

• Registration Number: NCT05237232
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-14
• Study Start: 2022-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Modeling cerebral vascularization	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.
Controls	Modeling cerebral vascularization	Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital.
Controls	Magnetic Resonance Angiography (MRA) additional acquisition time	Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital.

Primary Outcome Measures

Name	Time	Method
Intracerebral arterial flows of patients treated with ECMO	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 Outcome Measures

Name	Time	Method
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO	1 month	Brain Magnetic Resonance Angiography (MRA)
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy	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	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.

Trial Locations

Locations (1)

Hôpital Trousseau; 🇫🇷 Paris, France