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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04086056
Other study ID # 69HCL19_0568
Secondary ID 2019-A02390-57
Status Completed
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date October 11, 2023

Study information

Verified date February 2024
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 11, 2023
Est. primary completion date October 11, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Hospices Civils de Lyon service neurochirurgie pédiatrique Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regional cerebral oxygen saturation measure Variations of rScO2 (%, frequency of desaturations) measured by NIRS captors Day 0 before anesthesia
Primary Regional cerebral oxygen saturation measure Variations of rScO2 (%, frequency of desaturations) measured by NIRS captors Day 0 during surgery
Primary Regional cerebral oxygen saturation measure Variations of rScO2 (%, frequency of desaturations) measured by NIRS captors Day 0 after extubation
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