[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536303":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":65,"collaborators":10,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Infants undergoing craniosynostosis corrective surgery",null,"Infants aged 3 to 8 months with craniosynostosis admitted to the operating room of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria (AOU) of Bologna Polyclinic Sant'Orsola to undergo corrective surgery.",[13],"Procedure: Intraoperative monitoring",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","Intraoperative monitoring","ANESTHESIOLOGICAL MANAGEMENT accords to usual practice. Participants underwent preoperative fasting (3 h for breast milk, 4 h for formula milk, and 1 h for clear liquids), no premedication, induction and maintenance by sevoflurane, fentanyl boluses for analgesia, mechanical ventilation (PEEP 4 cm H2O, target tidal volume 6-8 ml\u002FKg, end tidal CO2 32-40 mmHg), 10 ml\u002FKg\u002Fh of intraoperative fluids. Scalp block is performed before surgery.\n\nMONITORING DURING SURGERY: monitor devices routinely used are connected to the participant: Dräger Infinity Delta XL®, Masimo® for pulse oximetry (Rainbow SET), regional cerebral oximetry (O3TM), and (optional) brain function monitoring (Masimo® SedLine). Arterial blood gas test is sampled at the anesthesiologist's discretion. After the artery catheterization, the MostCare® system is simultaneously connected to the patient monitoring devices. Data are collected every 3 minutes, 6 minutes for the noninvasive blood pressure measurement.",[9],[21],{"name":22,"affiliation":23,"role":24},"Maria Cristina Mondardini, MD","IRCCS AOU of Bologna Policlinico Sant'Orsola","PRINCIPAL_INVESTIGATOR",[26,31],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","051 2143650","+39","mariacristina.mondardini@aosp.bo.it",{"name":32,"role":27,"phone":10,"phoneExt":10,"email":33},"Fabio Caramelli, MD","fabio.caramelli@aosp.bo.it",[35],{"facility":23,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Bologna","BO","40138","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],11.33875,44.49381,{"lat":46,"lon":45},[49,53,57,60,61,63],{"name":50,"role":27,"phone":51,"phoneExt":29,"email":52},"Luigia Scudeller, MD","051 2141402","luigia.scudeller@aosp.bo.it",{"name":54,"role":27,"phone":55,"phoneExt":29,"email":56},"Barbara Lotito, MD","051 2141296","barbara.lotito@aosp.bo.it",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},"Lorena Pasini, MD","SUB_INVESTIGATOR",{"name":32,"role":59,"phone":10,"phoneExt":10,"email":10},{"name":62,"role":59,"phone":10,"phoneExt":10,"email":10},"Rosario Ruga, Student",{"name":64,"role":59,"phone":10,"phoneExt":10,"email":10},"Andrea La Placa, MD",{"type":24,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Maria Cristina Mondardini","Principal Investigator","100536303","hemodynamic-monitoring-during-craniosynostosis-surgery-comparing-traditional-and-newer-technology-monitors-crasy-pram-100536303",false,"NCT06263075","Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)","Evaluation of the Hemodynamic Variability During Craniosynostosis Surgery: a Comparison Between Traditional Hemodynamic Monitoring and Pressure Recording Analytic Method (CRASY-PRAM)","CRASY-PRAM","Inclusion Criteria:\n\n* Infants with craniosynostosis undergoing corrective surgery\n* Ages between 3 and 8 months\n* Physical status classification of the American Society of Anesthesiologists (ASA) \\\u003C\u002F= 2\n* Consent obtained from the patients' parents\u002Flegal guardians\n\nExclusion Criteria:\n\n* Congenital or acquired cardiac disease\n* Preoperative cardiac dysfunction\n* Metabolic diseases\n* Gestational age at birth \\\u003C30 weeks\n* Body weight less than 3 kg\n* Dislocation or malfunction of the arterial catheter\n* Malfunctioning of monitoring devices","ALL","3 Months","8 Months",{"count":80,"type":81},30,"ESTIMATED","OBSERVATIONAL","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.\n\nSurgical 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.\n\nThis 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.",[85,86,87,88],"Craniosynostoses","Hypovolemia","Hemorrhage","Hemodynamic Instability",[90,91],"Monitoring Physiologic","Monitoring Intraoperative","2025-09-30",{"date":94,"type":95},"2025-10-03","ACTUAL",{"date":97,"type":95},"2023-12-13",{"date":99,"type":81},"2026-06",{"name":5,"class":6},1]