[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513746":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":57,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Azienda Ospedaliera di Padova","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"sedated and ventilated pediatric critical care patients",null,"All sedated and ventilated critically ill patients will be exposed to the Masimo Sedline® sensor. Its pEEG scores, including the PSI, will be registered by the patient primary nurse every 4 hours for the first 5 days of ventilation. At the same time, CBS will be evaluated by a specialized PICU nurse and by a critical-care expert physician, blinded to each other. In case of chemically paralyzed patients, a paralysis holiday will be performed when clinically possible . A CBS will be assessed when the paralytic agents will be considered washed out. The patient's analgosedation strategy and analgosedation protocol will not be standardized but will be decided by the treating physician based on the international recommendations.",[13],"Device: pEEG monitoring",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","pEEG monitoring","pEEG monitoring during PICU admission",[9],[21],{"name":22,"affiliation":23,"role":24},"angela amigoni, MD","University Hospital of Padova","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+39 339 8333765","angela.amigoni@aopd.veneto.it",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"anna tessari","+ 39 3497804876","anna.tessari@aopd.veneto.it",[35],{"facility":23,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Padova","35128","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.14261,44.38225,{"lat":45,"lon":44},[48,49,52,55],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":50,"role":27,"phone":51,"phoneExt":10,"email":33},"anna tessari, MD","+39 349 7804876",{"name":53,"role":54,"phone":10,"phoneExt":10,"email":10},"francesca sperotto, PhD","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":10,"phoneExt":10,"email":10},"marco daverio, MD",{"type":24,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"angela amigoni","Director","100513746","validation-of-a-processed-eeg-device-for-monitoring-sedation-in-picu-100513746",false,"NCT05969483","Validation of a Processed EEG Device for Monitoring Sedation in PICU","Validation of a Processed EEG Device (pEEG, Masimo Sedline®) as a Monitoring Tool for the Analgosedation Level in Mechanically Ventilated Critically Ill Children","Inclusion Criteria:\n\n\\- sedated and ventilated patients admitted in PICU\n\nExclusion Criteria:\n\n* skin lesions\n* significant traumatic lesions in the area where the Masimo Sedline® sensor need to be applied.","FEMALE","1 Day","18 Years",{"count":71,"type":72},150,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational study is to validate pEEG as a monitoring tool for the analgosedation level in mechanically-ventilated critically ill children, receiving or not-receiving NMBAs. The main question aims to answer is to measure the strength of agreement between pEEG score and Comfort Behavioural Scale (CBS) (goal standard).\n\nParticipants will be monitored with pEEG and CBS evaluated during PICU admission. paralysis holiday) by a specialized PICU nurse and by a critical-care expert physician, blinded to each other.",[76],"Sedation Complication",[78,79,80],"sedation","pediatric intensive care","monitoring","2025-01-27",{"date":83,"type":84},"2025-01-28","ACTUAL",{"date":86,"type":84},"2022-10-01",{"date":88,"type":72},"2025-03",{"name":5,"class":6},1]