An observational study in Craniosynostoses, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 3 Months to 18 Months. Per ClinicalTrials.gov, last updated 2024-02-21.
Sponsored by Hospices Civils de Lyon · Observational
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Children with craniosynostosis.
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Exclusion Criteria:
Children with craniosynostosis who will be operated in prone position.
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.
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Time frame: Day 0 before anesthesia
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Time frame: Day 0 during surgery
Regional cerebral oxygen saturation measure
Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors
Time frame: Day 0 after extubation
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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