Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

Extra Corporeal Membrane Oxygenation Clinical Trial

— MoVa-ECMO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237232
• Other study ID #: APHP211306
• Secondary ID: 2021-A01935-36
• Status: Recruiting
• Start date: March 31, 2022
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Sabine Irtan, MD, PhD
• Phone: 1 71 73 87 98
• Email: sabine.irtan[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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 gadolinium contrast medium injection (study population)

2. Contraindication to MRA

3. Opposition of holders of parental authority

Related Conditions & MeSH terms

• Extra Corporeal Membrane Oxygenation

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Hôpital Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 CRIMSON digital fluid mechanics software.	1 month
Secondary	Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO	Brain Magnetic Resonance Angiography (MRA) with gadolinium contrast medium injection	1 month
Secondary	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
Secondary	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 CRIMSON digital fluid mechanics software.	1 month