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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02390-57 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with craniosynostosis | Children with craniosynostosis who will be operated in prone position. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS monitoring | Other | Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Regional cerebral oxygen saturation measure | Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors | Day 0 before anesthesia |
| Regional cerebral oxygen saturation measure | Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors | Day 0 during surgery |
| Regional cerebral oxygen saturation measure | Variations of rScO₂ (%, frequency of desaturations) measured by NIRS captors | Day 0 after extubation |
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Inclusion Criteria:
Exclusion Criteria:
- Craniosynostosis planned to be corrected by an endoscopic craniectomy or in dorsal position.
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Children with craniosynostosis.
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| Name | Affiliation | Role |
|---|---|---|
| Federico DI ROCCO | Hospices Civils de Lyon service neurochirurgie pédiatrique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon service neurochirurgie pédiatrique | Bron | 69500 | France |
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| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
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| D009140 |
| Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |