[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567413":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":35,"responsibleParty":65,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":83,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hospital Clínico Red de Salud UC-Christus",null,"Adult patients admitted to intensive care units at Hospital Clinico Red de Salud UC-Christus who require sedation and mechanical ventilation for more than 24 hours.",[13],"Drug: Sedative",{"label":15,"type":10,"description":16,"interventionNames":17},"Hospital Dr. Sotero del Rio","Adult patients admitted to intensive care units at Hospital Dr. Sotero del Rio who require sedation and mechanical ventilation for more than 24 hours.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Sedative","Patients admitted to intensive care units who require sedation and mechanical ventilation for more than 24 hours.",[9,15],[25],"Mechanical ventilation",[27],{"name":28,"affiliation":5,"role":29},"Juan C. Pedemonte, M.D.","STUDY_DIRECTOR",[31],{"name":28,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","+56 99 879 8836","jcpedemo@uc.cl",[36,53],{"facility":15,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"NOT_YET_RECRUITING","Santiago","Metropolitana de Santiago","7700642","Chile","CL",{"type":44,"coordinates":45},"Point",[46,47],-70.64827,-33.45694,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":10,"phoneExt":10,"email":52},"Andrés Aquevedo, M.D.","andres.aquevedo@gmail.com",{"facility":54,"status":55,"city":38,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Hospital Clínico Pontificia Universidad Católica de Chile","RECRUITING","Santiago Metropolitan","8330024",{"type":44,"coordinates":59},[46,47],{"lat":47,"lon":46},[62],{"name":63,"role":32,"phone":10,"phoneExt":10,"email":64},"Magdalena Vera, M.D.","mgvera@uc.cl",{"type":66,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[68],{"name":69,"class":6},"Agencia Nacional de Investigación y Desarrollo","100567413","multiparameter-monitoring-system-for-sedation-inthe-icu-100567413",false,"NCT06667869","multipaRameter mOnitoring systeM for sedAtion iNThe ICu","Sistema de monitorización multiparámetros Para sedación de Pacientes críticos en UCI (ROMANTIC: multipaRameter mOnitoring systeM for sedAtion iNThe ICu)","ROMANTIC","Inclusion Criteria:\n\n* Patients admitted to adult critical care units\n* Individuals over 18 years old\n* Requiring sedation for more than 24 hours\n* Patients needing mechanical ventilation for more than 24 hours\n\nExclusion Criteria:\n\n* Patients with neurological pathology as the cause of mechanical ventilation (including recovered cardiocirculatory arrest, fulminant liver failure, and neurocritical conditions, except subdural hematomas or subarachnoid hemorrhages).\n* Pregnancy\n* Presence of psychiatric or intellectual disability prior to hospitalization\n* Drug dependency\n* History of chronic liver damage with hepatic encephalopathy\n* Second period of mechanical ventilation during hospitalization\n* Early limitation of therapeutic effort\n* Patients under 18 years old","ALL","18 Years",{"count":81,"type":82},80,"ESTIMATED","2 Weeks","OBSERVATIONAL","The administration of sedation in Intensive Care Units (ICU) is a vital and complex task, essential for the well-being of critically ill patients. Proper dosing is crucial, as both under-dosing and overdosing have adverse consequences for patients, including risks such as accidental extubation, ventilator disconnections, delirium, prolonged ventilation, ICU stays, and even increased mortality.\n\nMonitoring sedation levels is essential to maintain a balance in sedative administration. Clinical scales (RASS\u002FSAS) are currently used as the reference method, but they have limitations. These scales may be inadequate when the patient is unresponsive or when neuromuscular blockers are used. An alternative is electroencephalography (EEG)-based monitors, though they also have limitations in accurately representing the level of hypnosis.\n\nThe proposal is to develop an advanced multiparameter system called ROMANTIC, which utilizes machine learning algorithms to monitor sedation status continuously. The aim is for this system to surpass current techniques and provide a more accurate determination of sedation levels. ROMANTIC would incorporate a variety of variables, demographic, pharmacological, hemodynamic, respiratory, and EEG data, to predict sedation status in three categories: under-dosing, appropriate dosing, and overdosing.\n\nWith ROMANTIC, clinical staff (users) are expected to be able to determine sedation levels more quickly and accurately, reducing patients' wake-up times and possibly decreasing the incidence of delirium. In the long term, this could result in fewer ICU bed days, less time on mechanical ventilation, cost savings, and reduced complications.\n\nAt the end of the project, the goal is to have a prototype model or software that allows non-specialized staff (users) to quickly determine sedation levels in the ICU. This machine learning-based model targets hospitals with ICUs and mechanical ventilation to offer more efficient and cost-effective clinical care. ROMANTIC seeks to innovate in sedation monitoring, providing a more advanced and precise tool for the care of critically ill patients (beneficiaries) in the ICU.",[87],"Sedation Complication",[89,90,91,25,92],"Intensive Care Unit","Machine Learning","Delirium","Monitoring","2025-06-04",{"date":95,"type":96},"2025-06-08","ACTUAL",{"date":98,"type":96},"2025-02-14",{"date":100,"type":82},"2026-12-15",{"name":5,"class":6},2]