CraNIRS Clinical Study

Craniosynostoses Clinical Trial

— CraNIRS  

Official title:

A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086056
• Other study ID #: 69HCL19_0568
• Secondary ID: 2019-A02390-57
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Craniosynostoses

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