CraNIRS Clinical Study

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2021

Interventions

  • Other: NIRS monitoring
    • Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.

Arms, Groups and Cohorts

  • Children with craniosynostosis
    • Children with craniosynostosis who will be operated in prone position.

Clinical Trial Outcome Measures

Primary Measures

  • Regional cerebral oxygen saturation measure
    • Time Frame: Day 0 before anesthesia
    • Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
  • Regional cerebral oxygen saturation measure
    • Time Frame: Day 0 during surgery
    • Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
  • Regional cerebral oxygen saturation measure
    • Time Frame: Day 0 after extubation
    • Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors

Participating in This Clinical Trial

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Gender Eligibility: All

Minimum Age: 3 Months

Maximum Age: 18 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Federico DI ROCCO, Principal Investigator, Hospices Civils de Lyon service neurochirurgie pédiatrique
  • Overall Contact(s)
    • Federico DI ROCCO, 4 72 35 75 72, federico.dirocco@chu-lyon.fr

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