Clinical Trial

Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

Study acronym: PVI-CRANIO
Recruiting
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Summary
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Patients aged 0-6 years will be monitored intraoperatively using standard anesthesia monitoring together with PVI and PI measurements. Hemodynamic parameters, including systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, blood loss, fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be recorded. The study will assess the association between PVI/PI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.
Trial Details
NCT Number NCT07657598
Lead Sponsor Muzaffer GENCER
Collaborators: Başakşehir Çam & Sakura City Hospital
Conditions Craniosynostosis
Enrollment 30 participants
Start Date 2024-08-01
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-18