Clinical trial NCT05237232: Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extra Corporeal Membrane Oxygenation
Decanulated Alive
Keywords: Extra corporeal membrane oxygenation
Pediatric patients
Arterial circulation
Techniques of carotid decanulation
Circle of Willis
Magnetic Resonance Angiography
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Intracerebral arterial flows of patients treated with ECMO
timeFrame: 1 month
Secondary outcomes:
measure: Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO
timeFrame: 1 month
measure: Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy
timeFrame: 1 month
measure: Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy
timeFrame: 1 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sabine Irtan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Garance Martin, MD
role: STUDY_DIRECTOR
References: