跳至主要内容
临床试验/NCT05237232
NCT05237232招募中不适用

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 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Intracerebral arterial flows of patients treated with ECMO

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • hypoxic-ischemic encephalopathy diagnosed at birth

排除标准

  • Contraindication to MRA
  • Opposition of holders of parental authority

结局指标

主要结局

Intracerebral arterial flows of patients treated with ECMO

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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