CraNIRS Clinical Study (CraNIRS)
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|ClinicalTrials.gov Identifier: NCT04086056|
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : January 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Craniosynostoses||Other: NIRS monitoring|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis|
|Actual Study Start Date :||January 20, 2020|
|Estimated Primary Completion Date :||January 28, 2022|
|Estimated Study Completion Date :||January 28, 2022|
Children with craniosynostosis
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 [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086056
|Contact: Federico DI ROCCO||4 72 35 75 72 ext +firstname.lastname@example.org|
|Contact: Mathilde DE QUEIROZ-SIQUEIRA||4 72 38 55 33 ext +email@example.com|
|Hospices Civils de Lyon service neurochirurgie pédiatrique||Recruiting|
|Bron, France, 69500|
|Contact: Federico DI ROCCO, MD 4 72 35 75 72 ext +33 firstname.lastname@example.org|
|Contact: Mathilde DE QUEIROZ-SIQUEIRA, MD 4 72 38 55 33 ext +33 email@example.com|
|Principal Investigator: Federico DI ROCCO|
|Sub-Investigator: Mathilde DE QUEIROZ-SIQUEIRA|
|Sub-Investigator: Eloïse CERCUEIL|
|Principal Investigator:||Federico DI ROCCO||Hospices Civils de Lyon service neurochirurgie pédiatrique|