[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641476":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":34,"collaborators":38,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":10,"maxAge":49,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Pediatric Craniosynostosis Surgery Cohort",null,"Pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. Pleth variability index (PVI), perfusion index (PI), standard hemodynamic variables, fluid administration, blood loss, transfusion requirements, urine output, blood gas parameters and intraoperative complications will be recorded during surgery.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Muzaffer Gencer, associate professor","CONTACT","+90 212 909 60 00","dr.m.gencer07@gmail.com",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":24,"country":25,"countryCode":10,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Basaksehir Cam and Sakura City Hospital","RECRUITING","Istanbul","Basaksehir","34480","Turkey (Türkiye)",{"type":27,"coordinates":28},"Point",[29,30],28.94966,41.01384,{"lat":30,"lon":29},[33],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Muzaffer GENCER","associate professor",[39],{"name":5,"class":6},"100641476","pleth-variability-index-monitoring-in-pediatric-craniosynostosis-surgery-100641476",false,"NCT07657598","Pleth Variability Index Monitoring in Pediatric Craniosynostosis Surgery","Association of Pleth Variability Index Monitoring With Intraoperative Hemodynamic Control in Pediatric Craniosynostosis Surgery","PVI-CRANIO","Inclusion Criteria:\n\n* Pediatric patients aged 0 to 6 years\n* Patients scheduled to undergo craniosynostosis surgery\n* American Society of Anesthesiologists physical status I, II or III\n* Written informed consent obtained from the parent or legal guardian\n\nExclusion Criteria:\n\n* Patients older than 6 years\n* American Society of Anesthesiologists physical status IV\n* Inappropriate preoperative fasting status\n* History of significant cardiac, pulmonary or renal disease\n* Patients operated at another institution and subsequently transferred to the study center\n* Patients with peripheral circulatory impairment\n* Withdrawal of consent by the parent or legal guardian","ALL","6 Years",{"count":51,"type":52},30,"ESTIMATED","OBSERVATIONAL","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\u002FPI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.",[56],"Craniosynostosis",[58,59,60,61,62,63,64],"Pleth Variability Index","Perfusion Index","Craniosynostosis Surgery","Pediatric Anesthesia","Hemodynamic Monitoring","Intraoperative Hemodynamics","Fluid Management","2026-06-13",{"date":67,"type":68},"2026-06-18","ACTUAL",{"date":70,"type":68},"2024-08-01",{"date":72,"type":52},"2028-02-01",{"name":36,"class":6},1]