CraNIRS Clinical Study

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

Sponsors

Lead Sponsor: Hospices Civils de Lyon

Source Hospices Civils de Lyon
Brief 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.

Overall Status Recruiting
Start Date January 20, 2020
Completion Date January 28, 2022
Primary Completion Date January 28, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Regional cerebral oxygen saturation measure Day 0 before anesthesia
Regional cerebral oxygen saturation measure Day 0 during surgery
Regional cerebral oxygen saturation measure Day 0 after extubation
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: NIRS monitoring

Description: Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.

Arm Group Label: Children with craniosynostosis

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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.

Gender: All

Minimum Age: 3 Months

Maximum Age: 18 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Federico DI ROCCO Principal Investigator Hospices Civils de Lyon service neurochirurgie pédiatrique
Overall Contact

Last Name: Federico DI ROCCO

Phone: 4 72 35 75 72

Phone Ext.: +33

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Hospices Civils de Lyon service neurochirurgie pédiatrique Federico DI ROCCO, MD 4 72 35 75 72 +33 [email protected] Federico DI ROCCO Principal Investigator Mathilde DE QUEIROZ-SIQUEIRA Sub-Investigator Eloïse CERCUEIL Sub-Investigator
Location Countries

France

Verification Date

January 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Children with craniosynostosis

Description: Children with craniosynostosis who will be operated in prone position.

Acronym CraNIRS
Study Design Info

Observational Model: Other

Time Perspective: Prospective

Source: ClinicalTrials.gov