CraNIRS Clinical Study

Civil Hospices of Lyon

Status

Completed

Conditions

Craniosynostoses

Treatments

Other: NIRS monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT04086056

69HCL19_0568

2019-A02390-57 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

3 to 18 months old

Volunteers

No Healthy Volunteers

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