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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Decanulated Alive
Extra Corporeal Membrane Oxygenation

Treatments

Other: Modeling cerebral vascularization
Other: Magnetic Resonance Angiography (MRA) additional acquisition time

Study type

Observational

Funder types

Other

Identifiers

NCT05237232
APHP211306
2021-A01935-36 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Hélène Morel; Sabine Irtan, MD, PhD

Data sourced from clinicaltrials.gov

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