[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575209":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":70,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Università degli Studi di Ferrara","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care sedation","ACTIVE_COMPARATOR","The patients will be sedated according to the current standard of care (Behavioral pain scale and Richmond Agitation-Sedation Scale).",[13],"Procedure: Sedation titration according to standard of care",{"label":15,"type":16,"description":17,"interventionNames":18},"EEG guided sedation","EXPERIMENTAL","The patients will be sedated according to the EEG derived indexes (qCON\u002FqNOX).",[19],"Device: Sedation titration according to qEEG",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Sedation titration according to qEEG","Sedation will be titrated according to the EEG derived indexes (qCON\u002FqNOX)",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Sedation titration according to standard of care","Sedation will be provided according to the standard of care of the unit (clinical scales)",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Gaetano Scaramuzzo, MD","CONTACT","0532239158","scrgtn@unife.it",[39,54],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":43,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Azienda Ospedaliera Universitaria Sant'Anna","RECRUITING","Ferrara","Italy","44100","IT",{"type":47,"coordinates":48},"Point",[49,50],11.62057,44.83804,{"lat":50,"lon":49},[53],{"name":34,"role":35,"phone":26,"phoneExt":26,"email":37},{"facility":55,"status":56,"city":57,"state":58,"zip":26,"country":43,"countryCode":45,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Azienda Ospedaliera Universitaria Federico II - \"Policlinico\"","NOT_YET_RECRUITING","Naples","Napoli",{"type":47,"coordinates":60},[61,62],14.26811,40.85216,{"lat":62,"lon":61},[65,69],{"name":66,"role":35,"phone":67,"phoneExt":26,"email":68},"Annachiara Marra, MD, PhD","800 184 715","dottmarraannachiara@gmail.com",{"name":66,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Gaetano Scaramuzzo","Principal investigator",[75],{"name":76,"class":6},"S. Anna Hospital","100575209","effect-of-goal-directed-analgesia-and-sedation-using-eeg-derived-qconqnox-in-icu-patients-100575209",false,"NCT06769308","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients","Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON\u002FqNOX in ICU Patients Undergoing Mechanical Ventilation: a Randomized Controlled Trial","SED_ICU","Inclusion Criteria:\n\nAge 18-90 years Admission to the ICU for less than 24 hours Expected mechanical ventilation for \\>48 hours Ongoing sedation\n\nExclusion Criteria:\n\nMechanical ventilation (MV) for less than 48 hours Patient or next of kin refusal to participate BMI \\> 35 Cerebrovascular disease Scheduled surgery Neuromuscular disease Presence of craniofacial trauma that prevents the placement of electrodes","ALL","18 Years","90 Years",{"count":89,"type":90},174,"ESTIMATED","INTERVENTIONAL",[93],"NA","Sedation and analgesia are fundamental tools for managing critical patients who require mechanical ventilation. However, recent scientific literature highlights that excessive sedation in these patients can increase the duration of mechanical ventilation and extend the overall length of stay in intensive care, as well as expose them to a higher risk of hypotension, venous thrombosis, and nosocomial pneumonia. The titration of sedation and analgesia in intensive care, on the other hand, is currently based primarily on clinical parameters (such as the onset of delirium, asynchronies with the ventilator, for example), which can lead to treatments not proportionate to the patient's needs.\n\nThe present study aims to evaluate the application, in an intensive care setting, of the Conox® system, a device already widely used in monitoring the anesthetic plan in the operating room. This tool would allow, through the processing of an EEG trace, the assessment of the level of sedation (qCON) and the probable algic response (qNOX), thus providing valuable information for the fine-tuning of the analgo-sedative plan.",[96,97],"Sedation Complication","Mechanical Ventilation Complication",[99],"ICU, sedation, analgesia, mechanical ventilation","2025-01-09",{"date":102,"type":103},"2025-01-10","ACTUAL",{"date":105,"type":103},"2024-01-01",{"date":107,"type":90},"2027-07-31",{"name":5,"class":6},2]