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Clinical Trials/NCT04086056
NCT04086056
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country40 target enrollmentJanuary 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Craniosynostoses
Sponsor
Hospices Civils de Lyon
Enrollment
40
Locations
1
Primary Endpoint
Regional cerebral oxygen saturation measure
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2020
End Date
October 11, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Regional cerebral oxygen saturation measure

Time Frame: Day 0 after extubation

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

Study Sites (1)

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