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Clinical Trials/NCT05237232
NCT05237232
Recruiting
Not Applicable

Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows

Assistance Publique - Hôpitaux de Paris1 site in 1 country30 target enrollmentMarch 31, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extra Corporeal Membrane Oxygenation
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
30
Locations
1
Primary Endpoint
Intracerebral arterial flows of patients treated with ECMO
Status
Recruiting
Last Updated
7 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 31, 2022
End Date
August 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For everyone :
  • Information and non-opposition of holders of parental authority
  • Newborn, infant and child \<20kg
  • Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
  • Performing a Magnetic Resonance Angiography (MRA) as part of the treatment
  • For patients treated with ECMO: study population
  • Hemodynamic or respiratory failure
  • Requiring the use of extracorporeal circulation with jugulo-carotid cannulation
  • Weaned alive off Extra corporeal membrane oxygenation (ECMO)
  • For patients with hypoxic-ischemic encephalopathy: control population

Exclusion Criteria

  • Contraindication to MRA
  • Opposition of holders of parental authority

Outcomes

Primary Outcomes

Intracerebral arterial flows of patients treated with ECMO

Time Frame: 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 Outcomes

  • Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO(1 month)
  • Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy(1 month)
  • Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy(1 month)

Study Sites (1)

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