Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

Recruiting now

Conditions studied: Craniosynostosis

In brief

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.

Key facts

Study ID

NCT07657598

Run by

Muzaffer GENCER

People needed

30

Starts

2024-08-01

Expected to finish

2028-02-01

Last updated by the study team

2026-06-18

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients aged 0 to 6 years
• Patients scheduled to undergo craniosynostosis surgery
• American Society of Anesthesiologists physical status I, II or III
• Written informed consent obtained from the parent or legal guardian

You may not qualify if…

• Patients older than 6 years
• American Society of Anesthesiologists physical status IV
• Inappropriate preoperative fasting status
• History of significant cardiac, pulmonary or renal disease
• Patients operated at another institution and subsequently transferred to the study center
• Patients with peripheral circulatory impairment
• Withdrawal of consent by the parent or legal guardian

Where it is running

• Basaksehir Cam and Sakura City Hospital — Istanbul, Basaksehir, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.