protocolSection identificationModule nctId: NCT06263075, orgStudyIdInfo id: 717/2023/Oss/AOUBo, secondaryIdInfos id: 6822, type: OTHER, domain: SirER (Emilia-Romagna Research Information System) platform, briefTitle: Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM), acronym: CRASY-PRAM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, class: OTHER, descriptionModule briefSummary: Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated.Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses.This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements., conditionsModule conditions: Craniosynostoses, conditions: Hypovolemia, conditions: Hemorrhage, conditions: Hemodynamic Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative monitoring, outcomesModule primaryOutcomes measure: Hemodynamic events occurring during surgery, secondaryOutcomes measure: Evaluation of changes in volemic status, secondaryOutcomes measure: Evaluation of changes in volemic status, secondaryOutcomes measure: Evaluation of changes in systemic vascular resistance, secondaryOutcomes measure: Evaluation of changes in cardiac function, secondaryOutcomes measure: Evaluation of changes in cardiac function, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 8 Months, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS AOU of Bologna Policlinico Sant'Orsola, status: RECRUITING, city: Bologna, state: BO, zip: 40138, country: Italy, contacts name: Luigia Scudeller, MD, role: CONTACT, phone: 051 2141402, phoneExt: +39, email: luigia.scudeller@aosp.bo.it, contacts name: Barbara Lotito, MD, role: CONTACT, phone: 051 2141296, phoneExt: +39, email: barbara.lotito@aosp.bo.it, contacts name: Lorena Pasini, MD, role: SUB_INVESTIGATOR, contacts name: Fabio Caramelli, MD, role: SUB_INVESTIGATOR, contacts name: Rosario Ruga, Student, role: SUB_INVESTIGATOR, contacts name: Andrea La Placa, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False