跳至主要内容
临床试验/NCT04086056
NCT04086056已完成不适用

A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Regional cerebral oxygen saturation measure

研究概览

简要总结

Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.

In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.

In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.

Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
3 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Boys and girls.
  • Aged 3 to 18 months old.
  • Subjects with a craniosynostosis diagnosis confirmed by imaging.
  • Craniosynostosis requiring a corrective surgery in ventral position.
  • Parents/ legal guardian must provide non opposition prior to participation in the study.

排除标准

  • Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.

结局指标

主要结局

Regional cerebral oxygen saturation measure

时间窗: Day 0 after extubation

Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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