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Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery

Recruitingn/aAges any - 6 YearsAllMuzaffer GENCER
NCT07657598 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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